Deflectable catheters, systems, and methods for the visualization and treatment of bodily passages

ABSTRACT

Deflectable catheters, systems, and methods of using deflectable catheters are described herein. An embodiment of a deflectable catheter comprises an elongate member, a handle, and a wire member. The elongate member has a shaft and a flexible member. The shaft defines a first lumen and a second lumen and the flexible member defines a passageway. The flexible member is attached to the shaft such that the passageway defined by the flexible member is in communication with each of the first lumen and second lumen defined by the shaft.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/946,231, filed Feb. 28, 2014. The disclosure of this relatedapplication is hereby incorporated into this disclosure in its entirety.

FIELD

The disclosure relates generally to medical devices, systems, andmethods. More particularly, the disclosure relates to medical devices,systems, and methods for the visualization and treatment of bodilypassages, such as an airway, sinus cavity, or sinus passage.

BACKGROUND

Obstructive Sleep Apnea (OSA) Syndrome is a respiratory disordercharacterized by periodic cessation of breathing caused by upper airwayobstruction. Sleep causes the muscles of the upper airway to relax andthe associated soft tissue to sag, resulting in narrowing or collapse ofthe upper airway, and consequent reduction in ventilation. Mild OSA canlead to fatigue, reduced alertness following sleep, and a generalreduction in productivity for the affected individual. Severe OSA canlead to sleep deprivation, hypoxemia, and depression.

OSA can have several causes, with each requiring a different remedy. Forexample, in some cases OSA can be the result of obesity and/or diabetes.In other cases, OSA is caused by the anatomy of the septum, turbinates,palate, tongue, pharyngeal wall, muscle tone in upper airway,epiglottis, and/or uvula. Therefore, individual treatment of OSArequires a study of the causes of OSA in the individual to determine theappropriate form of treatment.

The conventional approach to diagnosis of sleep disorders, such as OSA,has been to require an individual to participate in a “sleep study,”which is completed during natural sleep or artificially induced sleep.During a natural sleep study, the individual is outfitted with an arrayof sensors attached to the surface of the body and face that monitor theindividual's respiration, pulse, and blood oxygen saturation, amongother physiological statistics. During a drug induced sleep endoscopy(DISE), during which sleep is artificially induced using midazolam orpropofol, a scope is disposed within the airway to determine the sourceof the obstruction.

Conventional sleep studies, however, have several shortcomings. Forexample, during natural sleep studies visualization of the airway is notperformed, which prevents identifying potential obstructions.Artificially induced sleep studies require the use of anesthesia, whichincreases the risks associated with performing the study. In addition,inducing artificial sleep may alter the results of the sleep study dueto the sleep-inducing drug manipulating normal bodily functions. Forexample, the structural configuration and function of an airway may bealtered when using sleep-inducing drugs as compared to the structuralconfiguration and function of an airway during normal sleep. Moreover,artificially induced sleep studies are typically performed with theindividual laying on his or her back, which fails to provide dataregarding obstructions when the individual is in other sleepingposition.

Therefore, a need exists for improved medical devices, systems, andmethods for visualizing and treating bodily passages.

BRIEF SUMMARY OF SELECTED EMBODIMENTS

An example embodiment of a deflectable catheter that has a lengthwiseaxis comprises a handle, an elongate member, and a wire member. Thehandle has an actuator that is moveable between an actuator firstposition and an actuator second position. The elongate member comprisesa first shaft, a first flexible member, a second shaft, a tubularmember, a third shaft, a second flexible member, and a cap. The elongatemember is moveable between a substantially straight configuration whenthe actuator is in the actuator first position and a curvedconfiguration when the actuator is in the actuator second position. Thefirst shaft is attached to the handle and defines a first lumen and asecond lumen. The first flexible member is attached to the first shaftand has a proximal end, a distal end, and defines a passageway incommunication with each of the first lumen and second lumen defined bythe first shaft. The second shaft is attached to the first flexiblemember and defines a first lumen and a second lumen. Each of the firstlumen and second lumen defined by the second shaft is in communicationwith the passageway defined by the first flexible member. The firstlumen defined by the second shaft is disposed on a second shaftlengthwise axis that is parallel to the lengthwise axis of thedeflectable catheter. The tubular member is attached to the second shaftand defines a lumen in communication with each of the first lumen andsecond lumen defined by the second shaft. The third shaft is attached tothe tubular member and defines a first lumen and a second lumen. Each ofthe first lumen and second lumen defined by the third shaft is incommunication with the lumen defined by the tubular member. The secondlumen defined by the third shaft is disposed on a third shaft lengthwiseaxis that is parallel to the lengthwise axis of the deflectablecatheter. The second flexible member is attached to the third shaft andhas a proximal end, a distal end, and defines a passageway incommunication with each of the first lumen and second lumen defined bythe third shaft. The cap is attached to the second flexible member. Thewire member has a first end attached to the actuator and a second endattached to the elongate member. The wire member extends from the firstend through the first lumen defined by the first shaft, through thepassageway defined by the first flexible member, through the first lumendefined by the second shaft, through the lumen defined by the tubularmember, through the second lumen defined by the third shaft, and throughthe passageway defined by the second flexible member. The second shaftlengthwise axis and the third shaft lengthwise axis are opposablypositioned relative to the lengthwise axis of the deflectable catheter.

An example embodiment of a deflectable catheter system comprises aproximal housing, a deflectable catheter, and a tubular member. Thetubular member is attached to the proximal housing and the deflectablecatheter. The proximal housing has a proximal end, a distal end, and abody that defines a chamber, an irrigation port, a first opening, and asecond opening. The irrigation port has a passageway and an end. Thepassageway of the irrigation port is in communication with the chamberdefined by the proximal housing and the end of the irrigation portionhas a connector. The deflectable catheter has an elongate member, ahandle, a wire member, an imaging device, a data transfer cable, a firstoptical fiber, a second optical fiber, and an irrigation tube. Thehandle has a first opening, a second opening, and a chamber incommunication with the first opening and the second opening defined bythe handle. The tubular member has a proximal end, a distal end, and abody that defines a lumen that extends from the proximal end to thedistal end of the tubular member. The proximal end of the tubular memberis attached to the proximal housing such that the lumen defined by thetubular member is in communication with the chamber defined by theproximal housing. The distal end of the tubular member is attached tothe handle of the deflectable catheter such that the lumen defined bythe tubular member is in communication with the chamber defined by thehandle.

An example method of visualizing a bodily passage comprises the stepsof: introducing a deflectable catheter that has a deflectable catheterproximal end and a deflectable catheter distal end into a bodily passagesuch that the deflectable catheter distal end is disposed in the bodilypassage, the deflectable catheter comprises an elongate member, anactuator, and a wire member; advancing the actuator from an actuatorfirst position to an actuator second position such that a curve isdefined along the length of the elongate member and within the bodilypassage; allowing an interval of time to pass; advancing the actuatorfrom the actuator second position to the actuator first position;removing the deflectable catheter from the bodily passage.

DESCRIPTION OF FIGURES

FIG. 1 is a perspective view of a deflectable catheter in a firstconfiguration.

FIG. 2 is a partial sectional view of the deflectable catheterillustrated in FIG. 1, taken along the lengthwise axis of thedeflectable catheter.

FIG. 3 is a sectional view of the deflectable catheter illustrated inFIG. 1, taken along line 3-3.

FIG. 4 is an end view of the distal end of the deflectable catheterillustrated in FIG. 1.

FIG. 5 is a side view of the cap of the deflectable catheter illustratedin FIG. 1 free of the deflectable catheter.

FIG. 5A is a sectional view of the cap illustrated in FIG. 5, takenalong line 5A-5A.

FIG. 6 is an end view of the proximal end of the cap of the deflectablecatheter illustrated in FIG. 1 free of the deflectable catheter.

FIG. 7 is a partial side view of the deflectable catheter illustrated inFIG. 1 in a second configuration.

FIG. 8 is a partial sectional view of the deflectable catheterillustrated in FIG. 1, taken along the lengthwise axis of thedeflectable catheter.

FIG. 9 is a partial exploded view of the deflectable catheterillustrated in FIG. 1.

FIG. 10 is a perspective view of another deflectable catheter in a firstconfiguration.

FIG. 11 is a partial side view of the deflectable catheter illustratedin FIG. 10.

FIG. 12 is an end view of the distal end of the deflectable catheterillustrated in FIG. 10.

FIG. 13 is a sectional view of the deflectable catheter illustrated inFIG. 11, taken along line 13-13.

FIG. 14 is a sectional view of the deflectable catheter illustrated inFIG. 11, taken along line 14-14.

FIG. 15 is a partial sectional view of the deflectable catheterillustrated in FIG. 10, taken along the lengthwise axis of thedeflectable catheter.

FIG. 16 is a partial side view of the deflectable catheter illustratedin FIG. 10 in a second configuration.

FIG. 17 is a flowchart representation of a method of visualizing abodily passage using a deflectable catheter.

FIG. 18 is a partial top view of a deflectable catheter system.

FIG. 19 is a sectional view of the deflectable catheter systemillustrated in FIG. 18, taken along line 19-19.

FIG. 20 is a sectional view of the deflectable catheter systemillustrated in FIG. 18, taken along line 20-20.

FIG. 21 is a sectional view of another deflectable catheter system.

FIG. 22 is a partial sectional view of another deflectable catheter.

FIG. 23 is a flowchart representation of a method of visualizing abodily passage using a deflectable catheter system.

DESCRIPTION OF EMBODIMENTS

The following detailed description and the appended drawings describeand illustrate various example embodiments of deflectable catheters,deflectable catheter systems, methods of visualizing and/or treating abodily passage using a deflectable catheter, and methods of visualizingand/or treating a bodily passage using a deflectable catheter system.The description and illustration of these examples are provided toenable one skilled in the art to make and use a deflectable catheter,deflectable catheter system, practice a method of visualizing and/ortreating a bodily passage using a deflectable catheter, and to practicea method of visualizing and/or treating a bodily passage using adeflectable catheter system according to an embodiment. They are notintended to limit the scope of the claims in any manner.

The use of “e.g.,” “etc.,” “for instance,” “in example,” and “or” andgrammatically related terms indicate non-exclusive alternatives withoutlimitation, unless otherwise noted. The use of “optionally” andgrammatically related terms means that the subsequently describedelement, event, feature, or circumstance may or may not be present oroccur, and that the description includes instances where said element,event, feature, or circumstance occurs and instances where it does not.The term “attached” refers to the fixed, releasable, or integratedassociation of two or more elements and/or devices. Thus, the term“attached” includes releasably attaching or fixedly attaching two ormore elements and/or devices. As used herein, the terms “proximal” and“distal” are used to describe opposing axial ends of the particularelement or feature being described. The term “diameter” refers to thelength of a straight line passing from side to side through the centerof a body, element, or feature, and does not impart any structuralconfiguration on the body, element, or feature. The term “circumference”refers to a displacement measured along the exterior surface area of abody, element, or feature and does not impart any structuralconfiguration on the body, element, or feature. The use of “bodilypassage” or “body passage” refers to any passage within the body of ananimal, including, but not limited to, humans, and includes, but is notlimited to, elongate passages. The term “sinus passage” refers to thenasal passages, and includes, but is not limited to, eustachian tube(s),primary ostium, accessory ostium, and/or an opening defined by aventilation tube. The term “airway” refers to any airway including, butnot limited to, the nasal cavity, nasopharynx, oropharynx, pharynx,trachea, bronchial tubes, esophagus, and/or lungs. The term “sinuscavity” refers to the frontal, ethmoid, sphenoid, and/or maxillarysinus.

FIGS. 1, 2, 3, 4, 5, 5A, 6, 7, 8, and 9, illustrate a deflectablecatheter 8 that has a proximal end 9, a distal end 10, and a lengthwiseaxis 11. The deflectable catheter 8 includes an elongate member 12, ahandle 14, a wire member 16, an imaging device 18, a data transfer cable20, a first optical fiber 22, a second optical fiber 24, and anirrigation tube 25.

Elongate member 12 can have any suitable outside diameter and anysuitable length, and skilled artisans will be able to select a suitableoutside diameter and length for an elongate member according to aparticular embodiment based on various considerations, including thedesired bodily passage within which a deflectable catheter is intendedto be used. Example lengths considered suitable for an elongate memberinclude lengths between 60 centimeters and 150 centimeters, lengthsbetween about 60 centimeters and about 150 centimeters, and any otherlength considered suitable for a particular embodiment. Example outsidediameters considered suitable for an elongate member include outsidediameters between 1.0 millimeter and 8.0 millimeters, between about 1.0millimeter and about 8.0 millimeters, between 2.0 millimeters and 6.0millimeters, between about 2.0 millimeters and about 6.0 millimeters,between 3.0 millimeters and 5.0 millimeters, between about 3.0millimeters and about 5.0 millimeters, equal to, substantially equal to,or about 4.0 millimeters, outside diameters less than, or equal to, 4.0millimeters, and any other outside diameter considered suitable for aparticular embodiment.

The elongate member 12, and the components that form the elongate member12 (e.g., shaft, flexible member, tubular member), can be formed of anysuitable material and can be fabricated using any suitable method ofmanufacture. Skilled artisans will be able to select a suitable materialto form an elongate member, or a component that forms a portion of anelongate member (e.g., shaft, flexible member, tubular member), and asuitable method of manufacture according to a particular embodimentbased on various considerations, including the desired flexibility ofthe elongate member. Example materials considered suitable to form anelongate member, or a component that forms a portion of an elongatemember (e.g., shaft, flexible member, tubular member), includebiocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nickel-titanium alloy (e.g.,Nitinol), polymers, Pebax (Pebax is a registered trademark of AtoChimieCorporation of Allee des Vosges, Courbevoie, France), nylon,polyethylene, polyurethane, silicone, coiled materials, braidedmaterials, and any other material considered suitable for a particularapplication. Example methods of manufacture considered suitable tofabricate an elongate member, or a component that forms a portion of anelongate member (e.g., shaft, flexible member, tubular member), includeextrusion processes, molding processes, and any other method consideredsuitable for a particular application.

In the illustrated embodiment, elongate member 12 has a proximal end 26,a distal end 27, a first shaft 28, a first flexible member 29, and a cap30. Elongate member 12 has a first, straight, configuration, as shown inFIG. 1, and a second, curved, configuration, as shown in FIG. 7. Thefirst configuration is different than the second configuration. Whilethe elongate member 12 has been illustrated as being straight in thefirst configuration, an elongate member can have any suitableconfiguration in the first configuration, such as substantiallystraight, or partially straight.

The first shaft 28 has a proximal end 32, a distal end 34, a length 35,and a body that defines a first lumen 36 and a second lumen 38. Thelength 35 extends from the proximal end 32 to the distal end 34 of thefirst shaft 28. Each of the first lumen 36 and the second lumen 38extends from the proximal end 32 of the first shaft 28 to the distal end34 of the first shaft 28. The first lumen 36 has a diameter that is lessthan the diameter of the second lumen 38 and is sized and configured toreceive a portion of the wire member 16. The second lumen 38 is sizedand configured to receive a portion of the imaging device 18, datatransfer cable 20, first optical fiber 22, second optical fiber 24,and/or irrigation tube 25. Alternatively, the first lumen and/or secondlumen defined by a shaft can be sized and configured to receive devicesin addition to, or alternative to, those described herein.

While the body of the first shaft 28 has been illustrated as defining afirst lumen 36 and a second lumen 38, the body of the shaft of adeflectable catheter can define any suitable number of lumens, andskilled artisans will be able to select a suitable number of lumens forthe body of a shaft to define according to a particular embodiment basedon various considerations, including the number of curves intended to bedefined by an elongate member when it is in the second configuration.Example number of lumens considered suitable for the body of a shaft todefine include one, at least one, two, a plurality, three, four, five,six, and any other number considered suitable for a particularapplication.

The first flexible member 29 is attached to the distal end 34 of thefirst shaft 28 and has a proximal end 40, a distal end 42, a length 43,and defines a passageway 44. The length 43 of the first flexible member29 extends from the proximal end 40 to the distal end 42 of the firstflexible member 29. In the embodiment shown, the proximal end 40 of thefirst flexible member 29 is disposed over a portion of the exteriorsurface of the first shaft 28 and is attached to first shaft 28 using anadhesive. However, alternative embodiments can include a first flexiblemember that is formed as a distal portion of a shaft, attached to thedistal end of the first shaft, or embedded within the material thatforms the first shaft. The passageway 44 defined by the first flexiblemember 29 is in communication with each of the first lumen 36 and secondlumen 38 defined by the first shaft 28. In the embodiment illustrated,the length 35 of the first shaft 28 is greater than the length 43 of thefirst flexible member 29. However, alternative embodiments can include afirst shaft that has a length than is less than, equal to, orsubstantially equal to, the length of a first flexible member.

The first flexible member 29 (e.g., localized flexible region) isrelatively more flexible than the first shaft 28. Any suitable structureand/or material can be used to form a flexible member of an elongatemember. Skilled artisans will be able to select a suitable structure andmaterial to form a flexible member of an elongate member according to aparticular embodiment based on various considerations, including thedegree of curvature intended to be achieved when the deflectablecatheter is in a second configuration. In the illustrated embodiment,the first flexible member 29 is a compression spring (e.g., medicalgrade compression spring) that defines a helical configuration thatextends from the proximal end 40 of the first flexible member 29 to thedistal end 42 of the first flexible member 40. The use of a compressionspring provides a mechanism for returning the elongate member 12 to itsfirst, straight, configuration after it has achieved a second, curved,configuration. Alternative structures and/or materials consideredsuitable to form a flexible member include helical cut nickel-titaniumalloy (e.g., Nitinol) segments, helical cut polymer segments, malleablematerials that can be customized and/or shaped by a user using his orher hands, or another device, prior to, or during, the performance of aprocedure, and any other structure and/or material considered suitablefor a particular embodiment. A flexible member can be formed of anymaterial capable of moving between first and second configurations andreturning to its first configuration when no force is being applied tothe flexible member.

Optionally, the first flexible member of an elongate member, or anyflexible member of an elongate member, can comprise a localized flexibleregion of the elongate member that is relatively more flexible thandifferent regions of the elongate member. The localized flexible regionof the elongate member can extend along the entire circumference, or aportion of the circumference of the elongate member and between theproximal end of the elongate member and the distal end of the elongatemember, from the proximal end of the elongate member toward the distalend of the elongate member, or from the distal end of the elongatemember toward the proximal end of the elongate member. Some embodimentscan also include more than one, or a plurality of, localized flexibleregions (e.g., elongate member 212). A localized flexible region of anelongate member can comprise any suitable structure and/or materialcapable of forming a first region of an elongate member that it isrelatively more flexible than a second region of the elongate memberthat is different than the first region (e.g., shaft, flexible member).Skilled artisans will be able to select a suitable structure and/ormaterial to form a localized flexible region according to a particularembodiment based on various considerations, including the desiredflexibility intended to be imparted on the localized flexible region.Example materials considered suitable to form a localized flexibleregion of an elongate member include the materials that form an elongatemember, helical cut nickel-titanium alloy (e.g., Nitinol) segments,helical cut polymer segments, malleable materials that can be customizedand/or shaped by a user using his or her hands, or another device, priorto, or during, the performance of a procedure, and any other structureand/or material considered suitable for a particular embodiment. Alocalized flexible region can be formed of any material capable ofmoving between first and second configurations. For example, a shaft ofan elongate member can be formed of a first material and the localizedflexible region of the elongate member can be formed of a secondmaterial. The first material can be the same as, or different than, thesecond material. For example, the first material can have a firstdurometer hardness and the second material can have a second durometerharness that is less than the first durometer harness. Optionally, alocalized flexible region can comprise a portion of the elongate memberthat has a cross-sectional surface area that is less than other regionsof the elongate member that are different than the localized flexibleregions (e.g., shaft). Optionally, an elongate member can be acontinuous piece of material such that any localized flexible regionsincluded on the elongate member can be formed by the material that formsthe elongate member (e.g., helical cut portions of elongate member,recesses). Optionally, a localized flexible region can comprise one ormore reliefs (e.g., recesses, notches, cuts) defined on a portion of theelongate member.

As shown in FIG. 2, the cap 30 is attached to the distal end 42 of thefirst flexible member 29. As best illustrated in FIGS. 4, 5, 5A, and 6,the cap 30 has a lengthwise axis 30′, a proximal end 45, a distal end46, and a body that defines a shaft 47, a first shaft opening 47′, asecond shaft opening 47″, a flange 48, a passageway 49, a wire memberopening 50, a first optical fiber opening 51, a second optical fiberopening 52, and an irrigation opening 53. In the embodiment shown, theproximal end 45 of the cap 30 is disposed within the passageway 44defined by the first flexible member 29 and is attached to firstflexible member 29 using an adhesive. However, alternative embodimentscan include a cap that is attached to the distal end of the firstflexible member, or embedded within the material that forms the firstflexible member. Optionally, a cap can be omitted from an elongatemember and the various elements and features described as being attachedto a cap can be attached to the distal end, or a distal portion, of aflexible member, tubular member, or dual lumen shaft.

The shaft 47 extends from the proximal end 45 of the cap 30 to theflange 48 and has a length 47′″ and a first outside diameter 49′. Theflange 48 extends from the shaft 47 and away from the lengthwise axis30′ of the cap 30 and has a length 48′ and a second outside diameter51′. The length 48′ of the flange 48 is less than the length 47′″ of theshaft 47. The second outside diameter 51′ of the flange 48 is greaterthan the first outside diameter 49′ of the shaft 47. The passageway 49extends through the shaft 47 and the flange 48, from the proximal end 45of the cap 30 to the distal end 46 of the cap 30, and is sized andconfigured to receive a portion of imaging device 18 and/or datatransfer cable 20. Each of the wire member opening 50, first opticalfiber opening 51, second optical fiber opening 52, and irrigationopening 53 extends through the length 48′ of the flange 48. The wiremember opening 50 is sized and configured to receive a portion of wiremember 16 such that the wire member 16 can be attached to the cap 30within the wire member opening 50. The first optical fiber opening 51 issized and configured to receive a portion of first optical fiber 22 suchthat the first optical fiber 22 can be attached to the cap 30 within thefirst optical fiber opening 51. The second optical fiber opening 52 issized and configured to receive a portion of the second optical fiber 24such that the second optical fiber 24 can be attached to the cap 30within the second optical fiber opening 52. The irrigation opening 53 issized and configured to receive a portion of the irrigation tube 25 suchthat the irrigation tube 25 can be attached to the cap 30 within theirrigation opening 53.

Each of the first shaft opening 47′ and second shaft opening 47″ isdefined between the proximal end 45 of the cap 30 and the flange 48 andprovides access to the passageway 49. Each of the first shaft opening47′ and second shaft opening 47″ is sized and configured to allowsecurement of the imaging device 18 to the cap 30 using any suitableform of attachment, such as those described herein. For example, each ofthe first shaft opening 47′ and second shaft opening 47″ can be sizedand configured to allow an adhesive to be passed through each of theopenings such that the imaging device 18 can be attached to the cap 30.

In the embodiment shown, the first outside diameter 49′ of the shaft 47is sized and configured to be received by the passageway 44 defined bythe first flexible member 29. In the embodiment illustrated, the shaft47 is entirely disposed within the passageway 44 defined by the firstflexible member 29 such that the flange 48 is adjacent to, and contacts,to the distal end 42 of the first flexible member 29. Alternatively, theshaft 47 can be partially disposed within a passageway defined by aflexible member such that the flange does not contact the flexiblemember.

While cap 30 has been illustrated as having a particular structuralconfiguration, a cap can have any suitable structural configuration andthe illustrated cap 30 is merely an example of a suitable configurationof a cap. Skilled artisans will be able to select a suitable structuralconfiguration for a cap according to a particular embodiment based onvarious considerations, including the structural configuration of thelumen in which a portion of the cap is intended to be disposed. Examplestructural configurations considered suitable for a cap include capsthat define a passageway (e.g., passageway 49) that has an insidediameter between about 1.790 millimeters and about 1.830 millimeters,caps that define a passageway (e.g., passageway 49) that has an insidediameter equal to, substantially equal to, or about 1.810 millimeters,caps that define a wire member opening (e.g., wire member opening 50)equal to, substantially equal to, or about 0.356 millimeters, caps thatdefine an optical fiber opening (e.g., first optical fiber opening 51,second optical fiber opening 52), and/or a irrigation opening (e.g.,irrigation opening 53) equal to, substantially equal to, or about 0.55millimeters, caps that have a length from the proximal end of the cap tothe distal end of the cap equal to, substantially equal to, or about 6.2millimeters, caps that define a shaft opening (e.g., first shaft opening47′, second shaft opening 47″) equal to, substantially equal to, orabout 0.80 millimeters, and any other configuration considered suitablefor a particular embodiment.

While the first flexible member 29 has been described as beingadhesively attached to the first shaft 28 and the cap 30 has beendescribed as being adhesively attached to the first flexible member 29,a flexible member can be attached to a shaft and a cap can be attachedto a flexible member using any suitable structure for, or method of,attachment between two components. Skilled artisans will be able toselect a suitable structure for, or method of, attachment between aflexible member and a shaft and between a cap and a flexible memberaccording to an embodiment based on various considerations, includingthe materials that form the shaft, flexible member, and/or cap. Examplestructures for, and methods of, attachment between a shaft and aflexible member and between a cap and a flexible member consideredsuitable include using an adhesive, welding, fusing (e.g., heat fusing),using threaded connections, and any other structure for, or method of,attachment between two components considered suitable for a particularembodiment.

While the imaging device 18 has been described as being adhesivelyattached to the first flexible member 29, an imaging device can beattached to a flexible member using any suitable structure for, ormethod of, attachment between two components. Skilled artisans will beable to select a suitable structure for, or method of, attachmentbetween an imaging device and a flexible member according to anembodiment based on various considerations, including the materials thatform the imaging device and/or the flexible member. Example structuresfor, and methods of, attachment between an imaging device and a flexiblemember considered suitable include using an adhesive, welding, fusing(e.g., heat fusing), using threaded connections, and any other structurefor, or method of, attachment between two components considered suitablefor a particular embodiment.

Optionally, an elongate member can include a safety wire to preventoverextension of the elongate member and/or flexible member during use.For example, a safety wire that has a first end attached to the distalend of the first shaft and a second end attached to the cap can beincluded in a deflectable catheter. The safety wire can be formed of anysuitable material and have any suitable structural configuration.Example materials considered suitable to form a safety wire includestainless steel, polymers, and any other material considered suitablefor a particular embodiment. Example structural configurationsconsidered suitable for a safety wire include cross-sectionalconfigurations that are round, rectangular (e.g., flat wire), and anyother structural configuration considered suitable for a particularembodiment. While the optional safety wire has been described as beingattached at particular locations on an elongate member, a safety wirecan be attached at any suitable location on an elongate member capableof preventing overextension of an elongate member and/or a flexiblemember during use. For example, the first end of a safety wire can beattached to the proximal end of a shaft, the distal end of a shaft,between the proximal and distal ends of a shaft and on the exteriorsurface of the shaft, between the proximal and distal ends of a shaftand on the interior surface of the shaft, the proximal end of a flexiblemember, between the proximal and distal ends of a flexible member,and/or any other location considered suitable for a particularembodiment. Example locations considered suitable to attach the secondend of a safety wire include the distal end of a cap, between theproximal and distal end of a cap and on the exterior surface of the cap,between the proximal and distal end of a cap and on the interior surfaceof the cap, the flexible member between the first end of the safety wireand the distal end of the flexible member, the distal end of theflexible member, and/or any other location considered suitable for aparticular embodiment.

Any portion, or the entirety, of the length of elongate member 12 can belined and/or coated with any suitable material to reduce the coefficientof friction between the outer surface of the elongate member and thesurface in which the outer surface is intended to, or may, contact, orthe surface defining a lumen or passageway of an elongate member and thesurface of a device being passed through the lumen or passageway. Anysuitable lining and/or coating capable of reducing the coefficient offriction is considered suitable, and skilled artisans will be able toselect a suitable lining and/or coating according to a particularembodiment based on various considerations, such as the bodily passagewithin which the deflectable catheter is intended to be used. Examplelubricious coatings considered suitable to reduce the coefficient offriction include, but are not limited to, polymers such as polyethylene(PE), polytetrafluoroethylene (PTFE), hydrophilic coatings that becomelubricious upon wetting, and any other polymer or substance havingproperties that result in the lowering of the coefficient of frictionbetween two surfaces.

Handle 14 can have any suitable structural configuration, can be formedof any suitable material, and can be fabricated using any suitablemethod of manufacture. Skilled artisans will be able to select asuitable structural configuration, material, and a method of manufacturefor a handle according to a particular embodiment based on variousconsiderations, including the devices intended to be housed by thehandle. Example materials considered suitable to form a handle, or acomponent housed within a handle, include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, polymers, Pebax, nylon,polyethylene, polyurethane, silicone, and any other material consideredsuitable for a particular application. Example methods of manufactureconsidered suitable to fabricate a handle include extrusion processes,molding processes, and any other method considered suitable for aparticular application.

In the illustrated embodiment, the handle 14 is attached to the proximalend 32 of the first shaft 28 and has a housing first portion 56, ahousing second portion 58, an actuator housing 60, an actuator 62, andhouses a control board 64. Handle 14 is similar to the handle describedwith respect to FIGS. 1, 2, 2A, 2B, 2C, 3, 4, and 5, described in U.S.Nonprovisional application Ser. No. 14/191,535, filed Feb. 27, 2014, andentitled Medical Devices, Systems, and Methods for the Visualization andTreatment of Bodily Passages. The entire contents of this applicationare hereby incorporated by reference into this disclosure. While aparticular handle 14 has been illustrated as included in deflectablecatheter 8, any suitable handle can be used, and skilled artisans willbe able to select a suitable handle to use with a deflectable catheteraccording to a particular embodiment based on various considerations,including the treatment intended to be performed. Example alternativehandles considered suitable to include with a deflectable catheterinclude any of the handles described in U.S. Nonprovisional applicationSer. No. 14/191,535, filed Feb. 27, 2014, and entitled Medical Devices,Systems, and Methods for the Visualization and Treatment of BodilyPassages, and any other handle considered suitable for a particularembodiment.

The housing first portion 56 is adapted to be attached to the housingsecond portion 58. In the illustrated embodiment, as best shown in FIGS.8 and 9, the housing first portion 56 has a proximal end 66, a distalend 68, a first side 70, a second side 72, and a body 74. The first side70 of housing first portion 56 is opposably facing, or substantiallyopposably facing, the second side 72. The body 74 of housing firstportion 56 defines a cavity 76, a first notch 78, a second notch 78′, anactuator opening 80, a first toothed geometry 82, a second toothedgeometry 84, a plurality of recesses 86, and a plurality of apertures88.

The cavity 76 extends into the body 74 of housing first portion 56 fromthe second side 72 and is sized and configured to receive a portion ofactuator housing 60, actuator 62, control board 64, data transfer cable20, first optical fiber 22, second optical fiber 24, and/or irrigationtube 25. The first notch 78 extends into the body 74 from the secondside 72 and extends from the distal end 68 to the cavity 76. The firstnotch 78 is sized and configured to receive a portion of elongate member12. The second notch 78′ extends into the body 74 from second side 72and extends from a side of housing first portion 56 to the cavity 76.Second notch 78′ is sized and configured to receive a portion of theirrigation tube 25. The actuator opening 80 is defined between theproximal end 66 and the distal end 68 of the housing first portion 56and extends through the body 74 to provide access to the cavity 76. Eachof the first toothed geometry 82 and second toothed geometry 84 extendsinto the cavity 76, is disposed along the length of the actuator opening80, and is adapted to interact with a portion of actuator 62, asdescribed in more detail herein. Alternative to each of the firsttoothed geometry 82 and second toothed geometry 84 extending along thelength of the actuator opening 80, a first toothed geometry and/or asecond toothed geometry of a housing first portion can extend along aportion of the length of an actuator opening. Each recess of theplurality of recesses 86 extends into the body 74 of the housing firstportion 56 from the second side 72 and is sized and configured toreceive a portion of a protuberance of the plurality of protuberances104, as described in more detail below. Each aperture of the pluralityof apertures 88 extends through the body 74 of the housing first portion56 and is sized and configured to receive a portion of an attachmentmember (e.g., length of hook and loop fastener material) to attach thehandle 14 to an individual or other device (e.g., patient, bed ofpatient, medical cart).

In the illustrated embodiment, as best shown in FIGS. 8 and 9, thehousing second portion 58 has a proximal end 90, a distal end 92, afirst side 94, a second side 96, and a body 98. The first side 94 ofhousing second portion 58 is opposably facing, or substantiallyopposably facing, housing the second side 96. The body 98 of housingsecond portion 58 defines a cavity 100, a first notch 102, a secondnotch 102′, a plurality of protuberances 104, and a plurality ofapertures 106.

The cavity 100 of housing second portion 58 extends into the body 98from the first side 94 and is sized and configured to receive a portionof actuator housing 60, actuator 62, the control board 64, data transfercable 20, first optical fiber 22, second optical fiber 24, and/orirrigation tube 25. The first notch 102 extends into the body 98 fromthe first side 94 and extends from the distal end 92 to the cavity 100.The first notch 102 is sized and configured to receive a portion ofelongate member 12. The second notch 102′ extends into the body 98 fromthe first side 94 and extends from a side of the housing second portion58 to the cavity 100. The second notch 102′ is sized and configured toreceive a portion of the irrigation tube 25. The first notch 78′ andsecond notch 102′ cooperatively define a passageway 102″, as shown inFIG. 1, which is sized and configured to receive a portion of theirrigation tube 25. Each protuberance of the plurality of protuberances104 extends from the base of the cavity 100 and away from the secondside 96. A portion of a protuberance of the plurality of protuberances104 is sized and configured to be received by a recess of the pluralityof recesses 86 to achieve attachment of the housing first portion 56 tothe housing second portion 58. Each aperture of the plurality ofapertures 106 extends through the body 98 of the housing second portion58 and is sized and configured to receive a portion of an attachmentmember (e.g., length of hook and loop fastener material) to attach thehandle 14 to an individual or other device (e.g., patient, bed ofpatient, medical cart).

As shown in FIG. 8, the cavity 76 of housing first portion 56 and thecavity 100 of housing second portion 58 cooperatively form a housingchamber 108 that is in communication with each of the first lumen 36 andsecond lumen 38 defined by the first shaft 28. The housing chamber 108is sized and configured to house the actuator housing 60, a portion ofactuator 62, the control board 64, a portion of data transfer cable 20,a portion of first optical fiber 22, a portion of second optical fiber24, and/or a portion of irrigation tube 25. Thus, the handle 14 definesa chamber that is in communication with the lumens defined by the firstshaft 28.

Optionally, the body 74 of the housing first portion 56 and/or the body98 of the housing second portion 58 can define a notch, or opening, thatextends through the body 74 and/or body 98 and into housing chamber 108.The notch and/or opening can be sized and configured to receive aportion of another device and allow the device (e.g., communicationsdevice, HDMI cable) to pass through notch and/or opening such that itcan be attached to the control board 64.

While a plurality of recesses 86 and a plurality of protuberances 104have been illustrated as accomplishing attachment between housing firstportion 56 and housing second portion 58, any suitable structuralarrangement and/or method of attachment is considered suitable between ahousing first portion and a housing second portion. Skilled artisanswill be able to select a suitable structural arrangement and/or methodof attachment between a housing first portion and a housing secondportion according to a particular embodiment based on variousconsiderations, including the structural arrangement of an actuator. Anexample structural arrangement considered suitable includes forming ahousing first portion and housing second portion as an integralcomponent. Example structures for, and methods of, attachment between ahousing first portion and a housing second portion considered suitableinclude using an adhesive, welding, fusing (e.g., heat fusing), threadedfasteners, snap fit configurations, and any other method of attachmentconsidered suitable for a particular application.

While housing first portion 56 and housing second portion 58 have beenillustrated as having a particular structural configuration, a housingcan have any suitable structural configuration, and skilled artisanswill be able to select a suitable structural configuration for a housingaccording to a particular embodiment based on various considerations,including the structural arrangement of a control board and/or actuator.

Actuator housing 60 has a proximal end 110, a distal end 112, a firstside 114, a second side 116, and a body 118 that defines a recess 120, anotch 122, and a plurality of apertures 124. The first side 114 isopposably facing, or substantially opposably facing, the second side116. The recess 120 extends into the body 118 from the first side 114and is sized and configured to contain a portion of the actuator 62. Thenotch 122 extends into the body 118 from the first side 114 and extendsfrom the distal end 112 to the recess 120. Each aperture of theplurality of apertures 124 extends through the body 118 and is sized andconfigured to receive a portion of a protuberance of the plurality ofprotuberances 104. While the actuator housing 60 has been illustrated ashaving a particular structural configuration, an actuator housing canhave any suitable structural configuration, and skilled artisans will beable to select a suitable structural configuration for an actuatorhousing according to a particular embodiment based on variousconsiderations, including the structural arrangement of a housing firstportion and/or a housing second portion.

Actuator 62 comprises an actuator base 126 and an actuator control 128.Actuator base 126 comprises a proximal end 130, a distal end 132, afirst side 134, a second side 136, a first base support 138, a secondbase support 140, and a body 142 that defines a first protuberance 144,second protuberance 146, first toothed geometry 148, and second toothedgeometry 150. The first side 134 is opposably facing, or substantiallyopposably facing, the second side 136. Each of the first base support138 and second base support 140 is biased such that it defines a curvebetween the proximal end 130 and the distal end 132 when no force isbeing applied to the actuator 62. Each of the first protuberance 144 andsecond protuberance 146 extends from the first side 134 and away fromthe second side 136. Each of the first toothed geometry 148 and secondtoothed geometry 150 extends from the first side 134 and away from thesecond side 136 and is complementary to first toothed geometry 82 andsecond toothed geometry 84 defined by the body 74 of the housing firstportion 56. The first toothed geometry 82 and second toothed geometry 84are sized and configured to interact with the first toothed geometry 148and second toothed geometry 150 to provide releasable engagement betweenhousing first portion 56 and actuator 62 when no force is being appliedto the actuator 62.

The actuator control 128 has a first side 152, a second side 154, and abody 156 that defines a first recess 158, and second recess 160. Thefirst side 152 is opposably facing, or substantially opposably facing,the second side 154. As shown in FIG. 8, each of the first recess 158and second recess 160 extends into the body 156 of the actuator control128 from the second side 154 and toward the first side 152. The firstrecess 158 is sized and configured to receive a portion of the firstprotuberance 144 of the actuator base 126 and the second recess 160 issized and configured to receive a portion of the second protuberance 146of the actuator base 126 such that the actuator control 128 is attachedto the actuator base 126. While the actuator 62 has been illustrated ashaving a particular structural configuration, an actuator can have anysuitable structural configuration, and skilled artisans will be able toselect a suitable structural configuration for an actuator according toa particular embodiment based on various considerations, including thestructural arrangement of a housing first portion and/or a housingsecond portion.

Control board 64 can comprise any suitable structure and include anysuitable device, and skilled artisans will be able to select a suitablestructure and device to include on a control board according to aparticular embodiment based on various considerations, including theprocedure intended to be performed. Example structures consideredsuitable include stripboards, printed circuit boards, and any otherstructure considered suitable for a particular application. Exampledevices considered suitable to include on a control board include energystorage devices, light sources, power sources, storage devices (e.g.,computer-readable medium), data transfer devices, communication devices,high-definition multimedia interface (HDMI) compliant devices, HDMIports, mobile high-definition link (MHL) compliant devices, MHL ports,energy transfer devices, processors, one or more switches formanipulating the function of, or data received from, any of the devicesincluded on the control board, or attached to the control board, and anyother device considered suitable for a particular application. Forexample, a control board can include computer readable media such thatdata obtained during the performance of a procedure can be transferredto another device during, or subsequent to, the performance of theprocedure. In addition, or alternative to the embodiments describedherein, a control board can be adapted to be attached to a power sourceor another device (e.g., computer, network) using a data transfer cable(e.g., HDMI cable, MHL cable), communications device, or communicationscable, such that data obtained during the performance of a procedure canbe transferred to another device during, or subsequent to, theperformance of the procedure.

Control board 64 is adapted to obtain and process data and/or signalsfrom imaging device 18 and store the data and/or signals on a local orremote storage device, communicate the data and/or signals to anotherdevice, and/or display the data and/or signals on a display device(e.g., monitor, television). The data and/or signals can be processedinto any suitable format (e.g., S-video) and the functions of theimaging device 18, or the data received from imaging device 18, can becontrolled, for example, using a graphical user interface (GUI) and aninput device (e.g., mouse).

In the illustrated embodiment, control board 64 has a control board body162 that defines a plurality of apertures 164. Each aperture of theplurality of apertures 164 extends through control board body 162 and issized and configured to receive a portion of a protuberance of theplurality of protuberances 104 defined by housing second portion 58. Inthe illustrated embodiment, control board 64 is in signal communicationwith imaging device 18, first optical fiber 22, and second optical fiber24, as described in more detail herein.

Optionally, one or more data transfer devices can be operativelyattached to the control board 64 to transmit data to one or moredevices. Skilled artisans will be able to select a suitable datatransfer device to operatively attach to a control board to transferdata to one or more other devices according to a particular embodimentbased on various considerations, including the type of data beingtransferred. Example data transfer devices considered suitable tooperatively attach to a control board include data transmission cables,multi-conductor cables, coaxial cables, united serial bus (USB) cables,serial cables, Ethernet cables, HDMI cables, MHL cables, wirelesstransmission devices, and any other structure considered suitable for aparticular application. Optionally, the distal end of the control board,or any other suitable portion of a control board, can comprise an HDMIport, or other suitable port or attachment mechanism, such that controlboard can be operatively attached to another device, such as a computer,network, storage device, computer readable storage medium, or any othersuitable device, such as those described herein. Optionally, a handlecan omit the inclusion of a control board and an imaging device, firstoptic fiber, and second optic fiber can be attached to a device separatefrom a deflectable catheter, as described in more detail herein.

The actuator 62 is moveable between an actuator first position, as shownin FIG. 1, and an actuator second position, not shown (e.g., actuator isdisposed at the opposite end of the actuator opening 80, actuator isdisposed at a position proximal to the actuator first position).Movement of actuator 62 between the actuator first position and actuatorsecond position results in movement of elongate member 12 between thefirst, straight, configuration and the second, curved, configuration, asdescribed in more detail herein.

As shown in FIG. 8, the actuator 62 is attached to wire member 16 and isadapted to be releasably fixed in the actuator first position andactuator second position via the interaction of first toothed geometry82 with first toothed geometry 148 and second toothed geometry 84 withsecond toothed geometry 150. When a force is applied to actuator control128 toward housing second portion 58, each of the first base support 138and second base support 140 compresses against, or advances toward, theactuator housing 60 such that toothed geometries are not engaged withone another and the actuator 62 can be moved within actuator opening 80between its first and second positions. Alternatively, when no force isapplied to actuator control 128, each of the first base support 138 andsecond base support 140 compresses against and contacts the housingfirst portion 56 such that the toothed geometries defined by the housingfirst portion 56 and the actuator 62 are engaged with on another. Thus,the base supports 138, 140 have a first radius of curvature, or arestraight, when a force is being applied to the actuator control 128toward the housing second portion 58 and have a second radius ofcurvature when no force is being applied to the actuator control 128.The first radius of curvature is greater than the second radius ofcurvature. Engagement of the toothed geometries defined by the housingfirst portion 56 and the actuator 62 provides a mechanism to prevent, orsubstantially prevent, movement of elongate member 12, actuator 62,and/or wire member 16 when elongate member 12 is in the straightconfiguration or defines a desired radius of curvature. For example,including a mechanism for releasably fixing actuator 62 along the lengthof actuator opening 80 allows the configuration of elongate member 12 tobe releasably fixed, or substantially fixed, when a procedure is beingperformed.

While an actuator that is moveable along the length of a housing (e.g.,linear actuator) is illustrated, any suitable actuator can be used tomove an elongate member between a first configuration and secondconfiguration, and skilled artisans will be able to select a suitableactuator to include on a deflectable catheter according to a particularembodiment based on various considerations, including the radius ofcurvature intended to be defined by an elongate member when the actuatoris moved between an actuator first position and an actuator secondposition. Example actuators considered suitable include linearactuators, rotatable actuators, pivotable actuators, electro-mechanicalactuators, and any other actuator considered suitable for a particularapplication.

While housing first portion 56 has been illustrated as having firsttoothed geometry 82 and second toothed geometry 84 and actuator base 126has been illustrated as having first toothed geometry 148 and secondtoothed geometry 150, any suitable structural configuration capable ofmaintaining the position of an actuator in an actuator first positionand/or actuator second position, or a position between the actuatorfirst position and the actuator second position, can be used. Skilledartisans will be able to select a suitable structural configuration tomaintain the position of an actuator according to a particularembodiment based on various considerations, including the structuralarrangement of an elongate member. Example structural arrangementsconsidered suitable include, but are not limited to, snap-fitconfigurations, press-fit configurations, and any other structuralconfiguration considered suitable for a particular application.

Wire member 16 can have any suitable outside diameter and length, andskilled artisans will be able to select a suitable outside diameter andlength for a wire member according to a particular embodiment based onvarious considerations, including the desired bodily passage withinwhich a deflectable catheter is intended to be used. For example, wiremembers that have an outside diameter between about 0.003 inches andabout 0.015 inches or between about 0.008 inches and about 0.010 inchesare considered suitable.

Wire member 16 can be formed of any suitable material, and skilledartisans will be able to select a suitable material to form a wiremember according to a particular embodiment based on variousconsiderations, including the material that forms an elongate member.Example materials considered suitable to form a wire member includebiocompatible materials, materials that can be made biocompatible,braided materials, polymers, nylon, metals such as stainless steel,titanium, and nickel-titanium alloy (e.g., Nitinol), and any othermaterial considered suitable for a particular application. Any portion,or the entirety, of the length of wire member 16 can be lined and/orcoated with any suitable material to reduce the coefficient of frictionbetween the outer surface of the wire member 16 and the surface in whichthe outer surface is intended to, or may, contact. Any suitable liningand/or coating capable of reducing the coefficient of friction isconsidered suitable, and skilled artisans will be able to select asuitable lining and/or coating according to a particular embodimentbased on various considerations, such as the materials that form anelongate member. Example lubricious coatings considered suitable toreduce the coefficient of friction between a wire member and the surfacein which the outer surface is intended to, or may, contact includepolymers such as polyethylene (PE), polytetrafluoroethylene (PTFE),hydrophilic coatings that become lubricious upon wetting, and any otherpolymer or substance having properties that result in the lowering ofthe coefficient of friction between two surfaces. For example, aportion, or the entirety, of the length of wire member 16 can be linedand/or coated with a material to reduce the coefficient of frictionbetween the wire member 16 and the elongate member 12 when moving theelongate member 12 between a curved configuration and a straight, orsubstantially straight, configuration relative to embodiments that donot include a lining and/or coating.

In the illustrated embodiment, the wire member 16 comprises a wiremember first end 166, as shown in FIG. 8, and a wire member second end168, as shown in FIG. 4. The wire member first end 166 can be attachedto any suitable portion of the actuator 62. In the illustratedembodiment, the wire member first end 166 is attached to the firstprotuberance 144 of the actuator base 126. The wire member 16 extendsfrom the wire member first end 166 through the first lumen 36 defined bythe first shaft 28, through the passageway 44 defined by the firstflexible member 29, and is attached to the cap 30 within the wire memberopening 50 (e.g., using an adhesive, welding). As shown in FIG. 2, thewire member 16 is disposed between the first flexible member 29 and theexterior surface of the cap 30 from the flange 48 to the proximal end 45of the cap 30.

In the illustrated embodiment, each of the distal end of the first lumen36 and the wire member second end 168 is disposed on a plane thatextends from the lengthwise axis 11 of the deflectable catheter 8 whenthe elongate member 12 is in the straight configuration. Thus, thedistal end of the first lumen 36 and the wire member second end 168 arespaced longitudinally along the length of elongate member 12 and aredisposed linearly along elongate member 12 when the elongate member 12is in the straight configuration. This configuration provides amechanism for moving the elongate member 12 between a straightconfiguration and a curved configuration such that the distal end of thefirst lumen 36 and the wire member second end 168 are disposed in thesame plane during movement between the straight configuration and thecurved configuration. However, alternative embodiments can include anelongate member that has a wire member second end that is not disposedon the same plane as the distal end of the first lumen and thelengthwise axis of the elongate member when the elongate member is movedbetween the straight and curved configurations.

While the distal end of the first lumen 36 and the wire member secondend 168 are illustrated as disposed linearly along elongate member 12and on a plane that extends from the elongate member lengthwise axis 11,the distal end of a lumen defined by a shaft and a wire member secondend can be positioned at any suitable location relative to one anotheron an elongate member. Skilled artisans will be able to select asuitable position to locate the distal end of a lumen defined by a shaftrelative to a wire member second end of an elongate member according toa particular embodiment based on various considerations, including thestructural arrangement of the bodily passage within which a deflectablecatheter is intended to be used. Example locations considered suitableto position the distal end of a lumen defined by a shaft relative to awire member second end of an elongate member include positioning thedistal end of the lumen and the wire member second end such that theyare contained on a plane that extends from the elongate memberlengthwise axis, positioning the distal end of the lumen such it isdisposed on a first plane that extends from the elongate memberlengthwise axis and positioning the wire member second end such that itis disposed on a second plane that extends from the elongate memberlengthwise axis, the first plane is different than the second plane andis disposed at an angle to the second plane. Example angles consideredsuitable between a first plane that contains the distal end of a lumenand a second plane that contains a wire member second end include anangle equal to about 45 degrees, an angle between about 1 degree andabout 90 degrees, an angle about 90 degrees, an angle between about 90degrees and about 180 degrees, an angle between about 180 degrees andabout 270 degrees, an angle between about 270 degrees and about 360degrees, and any other angle considered suitable for a particularapplication. Thus, the distal end of a lumen defined by a shaft and awire member second end can be disposed linearly or offset from oneanother about the circumference of an elongate member relative to thelengthwise axis of the elongate member.

A wire member can be attached to an actuator (e.g., first protuberance144) using any suitable structure for, or method of, attachment betweentwo components, and skilled artisans will be able to select a suitablestructure for, or method of, attachment between a wire member and anactuator according to a particular embodiment based on variousconsiderations, including the material that forms the wire member and/oractuator. Example structures for, and methods of, attachment between awire member and an actuator considered suitable include, but are notlimited to, bonding a wire member and an actuator to one another, usingan adhesive, fusing, welding, tying a wire member to an actuator,passing a wire member through an aperture defined by an actuator (e.g.,actuator protuberance) and tying the wire member about the actuator,passing a wire member through an aperture defined by an actuator (e.g.,actuator protuberance) and attaching a stopper having an outsidediameter greater than the aperture defined by the actuator to the wiremember, using a set screw that passes through a threaded passagewaydefined by a portion of an actuator that can be tightened on a wiremember to achieve attachment, and any other structure for, or method of,attachment between two components considered suitable for a particularapplication.

While the wire member second end 168 is illustrated as attached to thecap 30 within the wire member opening 50, a wire member second end canbe attached at any suitable location along the length of a cap, elongatemember, shaft, and/or flexible member using any suitable structure for,or method of, attachment between two components. Skilled artisans willbe able to select a suitable location to attach a wire member second endto an elongate member and a suitable structure for, or method of,attachment between a wire member and an elongate member according to aparticular embodiment based on various considerations, including theaxial length of the elongate member and/or the radius of curvaturedesired to be achieved by the elongate member when in a secondconfiguration. Example structures for, and methods of, attachmentbetween a wire member and a cap, or any other portion of a deflectablecatheter, considered suitable include using an adhesive, welding, fusing(e.g., heat fusing), and any other structure for, or method of,attachment between two components considered suitable for a particularapplication.

In use, movement of actuator 62 away from elongate member distal end 28,as shown by arrow 170 in FIG. 8, from the actuator first position, asshown in FIG. 1, to the actuator second position (not shown) causes wiremember 16 to move in a proximal direction such that wire member firstend 166 advances away from the proximal end 26 of the elongate member12. This creates tension in the wire member 16 that results in movementof wire member second end 168 and elongate member 12 such that theelongate member 12 moves from a straight configuration, as shown in FIG.1, to a curved configuration, as shown in FIG. 7, in which elongatemember 12 defines a curve 172 at a radius of curvature 174. Movement ofactuator 62 toward elongate member distal end 28, in a directionopposite that of arrow 170, reduces, or eliminates, tension in wiremember 16 and results in elongate member 12 returning to the straightconfiguration. Thus, when actuator 62 is in the actuator first position,elongate member 12 is in the straight configuration and when actuator 62is in the actuator second position, elongate member 12 is in the curvedconfiguration.

When elongate member 12 is in the curved configuration, the portion ofelongate member 12 disposed distal to curve 172 is disposed at an angleto the portion of the elongate member 12 disposed proximal to curve 172relative to an axis that is parallel to the lengthwise axis 11 of thedeflectable catheter 8. The portion of an elongate member disposeddistal to a curve can be disposed at any suitable angle to the portionof the elongate member disposed proximal to the curve, and skilledartisans will be able to select a suitable angle according to aparticular embodiment based on various considerations, including thedesired procedure intended to be performed. Example angles consideredsuitable to define between a portion of an elongate member disposeddistal to a curve and a portion of an elongate member disposed proximalto the curve include angles between about 0 degrees and 180 degrees,about 45 degrees, about 90 degrees, about 120 degrees, and any otherangle considered suitable for a particular application.

The radius of curvature 174 defined by elongate member 12 can vary andbe based upon at least the material(s) that form the elongate member 12,the location of the actuator second position, the length of elongatemember 12, the length of wire member 16, the axial length of actuatoropening 80 as it relates to the length of elongate member 12, and/or thedistance between the distal end 34 of the first shaft 28 and the distalend 42 of the first flexible member 29. For example, if a small radiusof curvature 174 is desired, the length of wire member 16 can be reducedas it relates to the length of elongate member 12 and/or the length ofactuator opening 80 can be increased as it relates to the length ofelongate member 12. Alternatively, if a large radius of curvature 174 isdesired, the length of wire member 16 can be increased as it relates tothe length of elongate member 12 and/or the length of actuator opening80 can be decreased as it relates to the length of elongate member 12.Alternatively, adjustment of actuator 62 provides a mechanism formanipulating the radius of curvature 174 defined by elongate member 12such that a desired radius of curvature can be achieved. Residualtension in wire member 16 can be eliminated, or substantiallyeliminated, when actuator 62 is in the actuator first position (e.g.,actuator 62 is near, or at, the distal end of actuator opening 80) toconfigure the elongate member 12 such that it is straight, orsubstantially straight, along its length when the actuator 62 is in theactuator first position. Optionally, an elongate member can be formedsuch that one or more curves are predefined between an elongate memberproximal end and an elongate member distal end.

In the illustrated embodiment, the wire member 16 has a length that isgreater than the sum of the length 35 of the first shaft 28 and thelength 43 of the first flexible member 29. However, alternativeembodiments can include a wire member 16 that has any suitable length.Example lengths considered suitable for a wire member include lengthsthat are greater than, less than, or equal to, the length of an elongatemember, the length of a shaft, and/or the length of a flexible member.

Movement of an elongate member 12 between a straight configuration and acurved configuration allows the deflectable catheter 8 to be advancedthrough tortuous bodily passages, such as airways, sinus cavities,and/or sinus passages and to position the distal end 27 of the elongatemember 12. In addition, movement between a straight and curvedconfiguration allows for the elongate member 12 to be manipulated suchthat distal end 27 of the elongate member 12 can be positioned invarious configurations to view various aspects of a bodily passage(e.g., during the performance of a sleep study).

The imaging device 18 is disposed within the passageway 49 defined bythe cap 30, is attached within the passageway 49 defined by the cap 30,and is operatively coupled to the control board 64 by the data transfercable 20. Imaging device 18 is adapted to obtain images of featuresand/or material disposed distal to elongate member 12 and transmit theimages to the control board 64 via data transfer cable 20, or to anotherdevice wirelessly, or otherwise. Alternative to the imaging device 18being disposed at the distal end 27 of the elongate member 12, animaging device can be disposed between an elongate member proximal endand an elongate member distal end such that the imaging device isdisposed through an opening defined by the body of the elongate memberand can obtain images radially from the elongate member. Optionally, anobjective or image-forming lens can be disposed distal to imaging device18 that is adapted to focus an image upon the imaging device 18.

Imaging device 18 can comprise any suitable device and/or structurecapable of obtaining one or more images and transmitting the image toanother device. Any suitable imaging device can be used in a deflectablecatheter, and skilled artisans will be able to select a suitable imagingdevice to include with a deflectable catheter according to a particularembodiment based on various considerations, including the bodily passagein which the deflectable catheter is intended to be used. Exampleimaging devices considered suitable include self-scanning solid stateimaging devices, charge coupled (CCD) sensors, complementary metal-oxidesemi-conductor (CMOS) sensors, and any other imaging device consideredsuitable for a particular application. An example imaging deviceconsidered suitable includes the imaging device included on the eyeMAX(eyeMAX is a registered trademark of Richard Wolf GmbH Corporation ofKnittlingen, Federal Republic of Germany) endoscope with chipon-the-tip, or chip-in-tip, technology.

The data transmitted by imaging device 18 can comprise any suitable formof data, and skilled artisans will be able to select a suitable form ofdata to transmit from an imaging device according to a particularembodiment based on various considerations, including the type ofimaging device being used with a deflectable catheter. Example forms ofdata considered suitable include, but are not limited to, analog data,RGB data, RGB data that is digitized and then amplified, digital data,and any other data considered suitable for a particular application.

The data transfer cable 20 has a first end 176 operatively attached tocontrol board 64, as shown in FIG. 8, and a second end 178 operativelyattached to imaging device 18, as shown in FIG. 2. The data transfercable 20 can comprise any suitable structure capable of transmittingdata and/or power from one location to another, and skilled artisanswill be able to select a suitable structure to transmit data and/orpower according to a particular embodiment based on variousconsiderations, including the structural arrangement of an elongatemember. Alternatively, the data transfer cable 20 can be omitted andimaging device 18 can be operatively connected to a wireless datatransmission device, located at any suitable location on a deflectablecatheter 8 (e.g., cap 30, control board 64), such that the imagesobtained by the imaging device 18 can be wirelessly transmitted to acontrol board or other device. Alternatively, the imaging device 18 canbe directly attached to a display, or other device, using the datatransfer cable 20 to provide still and/or live footage to the displayfor review by a user. Alternatively, multiple imaging devices can beused in conjunction with, or separate from, one another.

The first optical fiber 22 has a first end 180 operatively attached to alight source 182 included on the control board 64, as shown in FIG. 8,and a second end 184 disposed within the first optical fiber opening 51defined by the cap 30, as shown in FIG. 4. The first optical fiber 22 isattached to the cap 30 within the first optical fiber opening 51. Thesecond optical fiber 24 has a first end 186 operatively attached to thelight source 182 included on the control board 64, as shown in FIG. 8,and a second end 188 disposed within the second optical fiber opening 52defined by the cap 30, as shown in FIG. 4. The second optical fiber 24is attached to the cap 30 within the second optical fiber opening 52.Each of the first optical fiber 22 and the second optical fiber 24defines a light path along its length. Light generated by the lightsource 182 travels through the light path defined by first optical fiber22 and second optical fiber 24 and is emitted axially from each opticalfiber second end 184, 188. Each of the first optical fiber 22 and thesecond optical fiber 24 can be attached to the cap 30 using any suitablestructure for, or method of, attachment between two components. Examplestructures for, and methods of, attachment between an optical fiber anda cap considered suitable include using an adhesive, welding, fusing(e.g., heat fusing), using threaded connections, and any other structureor method of attachment considered suitable for a particular embodiment.

Any suitable optical fiber can be used in combination with deflectablecatheter, and skilled artisans will be able to select a suitable opticalfiber to include on a deflectable catheter according to a particularembodiment based on various considerations, including the desired bodilypassage within which the deflectable catheter is intended to bedisposed. Example optical fibers considered suitable include, but arenot limited to, commercially available optical fibers such as plasticoptical fibers and glass optical fibers, with or without cladding.

Any suitable light source can be included on a control board of adeflectable catheter, and skilled artisans will be able to select asuitable light source to include on a control board according to aparticular embodiment based on various considerations, including thetype of treatment intended to be performed. Example light sourcesconsidered suitable include, but are not limited to,commercially-available light sources such as xenon, laser, LED, andhalogen light sources. Alternatively, the first end of an optical fibercan be attached to a light source that is separate from a control board.Optionally, the light source can include a fiber coupling (not shown)which provides communication between a light source and a first opticalfiber and a second optical fiber.

It is noted that while a first optical fiber 22 and a second opticalfiber 24 have been illustrated, one or more different optical fibers canbe used in combination, or independently, to provide axially directedand/or radially directed light. The one or more optical fibers canextend through the same or different lumens of an elongate member andcan be operatively connected or attached to the same or two differentlight sources.

The irrigation tube 25 comprises an elongate tubular member that has afirst end 190, as shown in FIG. 1, a second end 192, as shown in FIG. 4,and defines a lumen 194 and a bend 196. The lumen 194, as shown in FIG.2, extends from the first end 190 to the second send 192 of theirrigation tube 25. The first end 190 is disposed within the passageway102″ cooperatively defined by the second notch 78′ defined by thehousing first portion 56 and the second notch 102′ defined by thehousing second portion 58. The irrigation tube 25 can have any suitableoutside diameter, length, and be formed of any suitable material.Example outside diameters considered suitable for a irrigation tubeinclude outside diameters that are less than the inside diameter of thesecond lumen defined by a shaft, diameters that are less than the insidediameter of the passageway cooperatively defined by first and secondhousing portions, and any other diameter considered suitable for aparticular embodiment. Example lengths considered suitable for anirrigation tube include lengths that are greater than the length of theelongate member, lengths that are greater than a shaft, lengths that aregreater than a flexible member, and any other length considered suitablefor a particular embodiment. Example materials considered suitable toform an irrigation tube include biocompatible materials, materials thatcan be made biocompatible, metals such as stainless steel, titanium,nickel-titanium alloy (e.g., Nitinol), polymers, Pebax, nylon,polyethylene, polyurethane, silicone, coiled materials, braidedmaterials, and any other material considered suitable for a particularapplication.

The first end 190 of the irrigation tube 25 is disposed outside of thepassageway 190 cooperatively defined by the housing first portion 56 andthe housing second portion 58 and can include any suitable connectorand/or adapter capable of attaching one or more devices to theirrigation tube 25. Skilled artisans will be able to select a suitableconnector and/or adapter to include on the first end of an irrigationtube according to a particular embodiment based on variousconsiderations, including the materials that form the irrigation tube.Example connectors and/or adapters considered suitable to include on anirrigation tube include threaded connectors, Tuohy Borst adapters, luerlock connectors, and any other connector and/or adapter consideredsuitable for a particular embodiment.

As shown in FIG. 4, the irrigation tube 25 is disposed within, andattached to, the irrigation opening 53 defined by the cap 30. Theirrigation tube 25 defines the bend 196 between the first end 190 andsecond end 192 of the irrigation tube 25 such that the second end 192 ofthe irrigation tube 25 can be oriented in any manner considered suitablefor a particular embodiment. For example, in the illustrated embodiment,the second end 192 of the irrigation tube 25 is directed toward thedistal end of the imaging device 18 (e.g., toward the lengthwise axis ofthe elongate member) such that irrigation fluid can be passed throughthe lumen 194 defined by the irrigation tube 25 and the imaging device18 can be cleaned during the performance of a procedure. The irrigationtube 25 can be attached to the cap 30 using any suitable structure for,or method of, attachment between two components. Example structures for,and methods of, attachment between an irrigation tube and a capconsidered suitable include using an adhesive, welding, fusing (e.g.,heat fusing), using threaded connections, and any other structure ormethod of attachment considered suitable for a particular embodiment.

Alternative to defining a bend, an irrigation tube can define anaperture at, or near, the second end of the irrigation tube that isdirected toward the imaging device (e.g., aperture is defined at anangle relative to the lengthwise axis of the irrigation tube).Alternative to defining a bend, a stainless steel tubular member can bedisposed within the distal opening of an irrigation tube. In thesealternative embodiments, the irrigation tube can be formed of a polymer,or other suitable material, and the stainless steel tubular member candefine a bend between its proximal and distal ends such that when theirrigation tube is attached within the cap, the distal end of thestainless steel tubular member is directed toward an imaging deviceand/or the lengthwise axis of the deflectable catheter.

In the embodiment illustrated, each of the wire member 16, first opticalfiber 22, second optical fiber 24, and irrigation tube 25 is disposedbetween the interior surface of the first flexible member 29 and theexterior surface of the shaft 47 of the cap 30 from the proximal end 45of the cap 30 to the flange 48. Alternatively, a tubular member can beattached to the shaft of a cap such that the exterior surface of thetubular member is attached to a first flexible member and each of thewire member, first optical fiber, second optical fiber, and irrigationtube is disposed within the tubular member, disposed between theinterior surface of the tubular member and the shaft of the cap, andextend to an opening defined by the flange of the cap, as describedherein. Alternatively, a dual lumen shaft can be attached to the shaftof a cap such that the exterior surface of the dual lumen shaft isattached to a first flexible member and the wire member is disposed in afirst lumen defined by the dual lumen shaft and each of the firstoptical fiber, second optical fiber, and irrigation tube is disposed ina second lumen defined by the dual lumen shaft. The dual lumen shaft canbe attached to the cap such that the lumen within which the wire memberis disposed is coaxial with the wire member opening defined by the cap.Each of the first optical fiber, second optical fiber, and irrigationtube extends through the second lumen defined by the dual lumen shaftand is disposed between the interior surface of the second lumen definedby the dual lumen shaft and the exterior surface of the shaft of thecap, and extend to an opening defined by the flange of the cap, asdescribed herein.

While a portion of the wire member 16 has been illustrated as beingdisposed within the first lumen 36 defined by the first shaft 28 and aportion of each of the imaging device 18, data transfer cable 20, firstoptical fiber 22, second optical fiber 24, and irrigation tube 25 hasbeen illustrated as being disposed within the second lumen 38 defined bythe first shaft 28, other configurations are considered suitable. Forexample, a portion of a wire member can be positioned within the secondlumen defined by a shaft and/or a portion of an imaging device, datatransfer cable, first optical fiber, second optical fiber, and/orirrigation tube can be positioned in the first lumen defined by a shaft.Alternatively, depending on the structural arrangement of a shaft, thecomponents can be disposed within a lumen defined by a shaft independentof any other component (e.g., shaft defines a lumen for each component)or each component can be disposed within the same lumen defined by ashaft (e.g., shaft defines a single lumen). Optionally, an imagingdevice, data transfer cable, first optical fiber, second optical fiber,and/or irrigation tube can be omitted from a deflectable catheter.

FIGS. 10, 11, 12, 13, 14, 15, and 16, illustrate another deflectablecatheter 208. The deflectable catheter 208 is similar to the deflectablecatheter 8 illustrated in FIGS. 1, 2, 3, 4, 5, 5A, 6, 7, 8, and 9, anddescribed above, except as detailed below. Reference numbers in FIGS.10, 11, 12, 13, 14, 15, and 16 refer to the same structural element orfeature referenced by the same number in FIGS. 1, 2, 3, 4, 5, 5A, 6, 7,8, and 9, offset by 200. Thus, the deflectable catheter 208 includes anelongate member 212, a handle 214, a wire member 216, an imaging device218, a data transfer cable 220, a first optical fiber 222, a secondoptical fiber 224, and an irrigation tube 225. The imaging device 218,data transfer cable 220, first optical fiber 222, second optical fiber224, and irrigation tube 225 have been omitted from FIGS. 10, 11, 15,and 16 for clarity.

In the illustrated embodiment, the elongate member 212 has a proximalend 226, a distal end 227, a first shaft 228, a first flexible member229, a second shaft 402, a tubular member 404, a third shaft 406, asecond flexible member 408, a safety wire 410, and a cap 230. The safetywire 410 has only been illustrated in FIGS. 13, 14, and 15 for clarity.The elongate member 212 has a first, straight, configuration, as shownin FIG. 10, and a second, curved, configuration, as shown in FIG. 16.

Elongate member 208 can have any suitable outside diameter and anysuitable length, and skilled artisans will be able to select a suitableoutside diameter and length for an elongate member according to aparticular embodiment based on various considerations, including thedesired bodily passage within which a deflectable catheter is intendedto be used. Example lengths considered suitable for an elongate memberinclude lengths between 60 centimeters and 150 centimeters, lengthsbetween about 60 centimeters and 150 centimeters, and any other lengthconsidered suitable for a particular embodiment. Example outsidediameters considered suitable for an elongate member include outsidediameters between 1.0 millimeter and 8.0 millimeters, between about 1.0millimeter and about 8.0 millimeters, between 2.0 millimeters and 6.0millimeters, between about 2.0 millimeters and about 6.0 millimeters,between 3.0 millimeters and 5.0 millimeters, between about 3.0millimeters and about 5.0 millimeters, equal to, substantially equal to,or about 4.0 millimeters, outside diameters less than, or equal to, 4.0millimeters, and any other outside diameter considered suitable for aparticular embodiment.

The second shaft 402 has a proximal end 412, a distal end 414, and abody that defines a first lumen 416 and a second lumen 418. Each of thefirst lumen 416 and the second lumen 418 extends from the proximal end412 of the second shaft 402 to the distal end 414 of the second shaft402. The first lumen 416 has a diameter that is less than the diameterof the second lumen 418. The first lumen 416 is sized and configured toreceive a portion of the wire member 216 and a portion of the safetywire 410. The second lumen 418 is sized and configured to receive aportion of the imaging device 218, data transfer cable 220, firstoptical fiber 222, second optical fiber 224, and/or irrigation tube 225.In the embodiment illustrated, the first lumen 236 defined by the firstshaft 228 is disposed on a first shaft lengthwise axis and the firstlumen 416 defined by the second shaft 402 is disposed on a second shaftlengthwise axis. The first shaft lengthwise axis and second shaftlengthwise axis are coaxial and parallel to the lengthwise axis 211 ofthe deflectable catheter 208. However, the first lumen defined by afirst shaft can be disposed on a first axis that is disposed on a firstplane that contains the lengthwise axis of the deflectable catheter andthe first lumen defined by a second shaft can be disposed on a secondaxis that is disposed on a second plane that contains the lengthwiseaxis of the deflectable catheter. The first plane can be disposed at anangle to the second plane relative to the lengthwise axis of thedeflectable catheter. Example angles considered suitable between a firstplane and a second plane include angles equal to about 45 degrees,angles between about 1 degree and about 90 degrees, angles about 90degrees, angles between about 90 degrees and about 180 degrees, anglesbetween about 180 degrees and about 270 degrees, angles between about270 degrees and about 360 degrees, angles less than, great than, orequal to 45 degrees, and any other angle considered suitable for aparticular application. Thus, the first lumen defined by a first shaftcan be coaxial or offset from the first lumen defined by a second shaft.

In the embodiment illustrated, the second shaft 402 is attached to thedistal end of the first flexible member 229 such that a portion of thesecond shaft 402 is disposed within the passageway 244 defined by thefirst flexible member 229. The first flexible member 229 is attached tothe second shaft 402 using an adhesive. Alternatively, a second shaftcan be attached to the distal end of a first flexible member, orembedded within the material that forms the first flexible member. Thedistal end 234 of the first shaft 228 is disposed from the proximal end412 of the second shaft 402 a distance 403 as measured when thedeflectable catheter 208 is in the straight configuration. In theembodiment illustrated, the distance 403 is equal to 3.0 millimeters.

While the distal end 234 of the first shaft 228 has been illustrated asdisposed from the proximal end 412 of the second shaft 402 a distance403, the distal end of a first shaft can be disposed any suitabledistance from the proximal end of a second shaft when a deflectablecatheter is in the straight configuration. Skilled artisans will be ableto select a suitable distance between the distal end of a first shaftand the proximal end of a second shaft according to a particularembodiment based on various considerations, including the degree ofcurvature intended to be accomplished when a deflectable catheter is inthe second configuration. Example distances considered suitable betweenthe distal end of a first shaft and the proximal end of a second shaftinclude distances equal to 3.0 millimeters, equal to about 3.0millimeters, equal to between 1.0 millimeter and 4.0 millimeters, equalto between about 1.0 millimeter and about 4.0 millimeters, and any otherdistance considered suitable for a particular embodiment. For example, afirst embodiment of a deflectable catheter can have a first distancedisposed between the distal end of a first shaft and the proximal end ofa second shaft and a second embodiment of a deflectable catheter canhave a second distance disposed between the distal end of a first shaftand the proximal end of a second shaft that is less than the firstdistance. The first embodiment can define a radius of curvature in thesecond configuration that is less than a radius of curvature that thesecond embodiment can define when it is in the second configuration.Thus, by increasing the distance between the distal end of a shaft andthe proximal end of another shaft, the radius of curvature can bedecreased.

The first flexible member 229 has a length 243 that is greater than thedistance 403 between the distal end 234 of the first shaft 228 and theproximal end 412 of the second shaft 402. In the embodiment illustrated,the first flexible member 229 has a length 243 that is equal to 1.0centimeter. However, alternative embodiments can include a firstflexible member that has a length that is less than, equal to, orsubstantially equal to, the distance between the distal end of a firstshaft and the proximal end of a second shaft. While the first flexiblemember 229 has been illustrated as having a particular length 243, aflexible member of a deflectable catheter can have any suitable length.Skilled artisans will be able to select a suitable length for a flexiblemember of a deflectable catheter according to a particular embodimentbased on various considerations, including the degree of curvatureintended to be accomplished when the deflectable catheter is in thesecond configuration. Example lengths considered suitable for a flexiblemember of a deflectable catheter include lengths equal to 1.0centimeter, equal to about 1.0 centimeter, equal to between 0.5centimeters and 1.5 centimeters, equal to between about 0.5 centimetersand about 1.5 centimeters, and any other length considered suitable fora particular embodiment.

The tubular member 404 is attached to the distal end 414 of the secondshaft 402 and has a proximal end 420, a distal end 422, and a body thatdefines a lumen 424. The lumen 424 defined by the tubular member 404extends from the proximal end 420 of the tubular member 404 to thedistal end 422 of the tubular member 404 and is in communication witheach of the first lumen 416 and second lumen 418 defined by the secondshaft 402. In the embodiment shown, a portion of the second shaft 402 isdisposed within the lumen 424 defined by the tubular member 404 and theproximal end 420 of the tubular member 404 is disposed over a portion ofthe exterior surface of the second shaft 402. The tubular member 404 isattached to the second shaft 402 using an adhesive. However, alternativeembodiments can include a tubular member that is attached to the distalend of a shaft, or embedded within the material that forms a shaft.Alternatively, a tubular member can be directly attached to a flexiblemember. For example, a tubular member can have a proximal end and/ordistal end that is attached to the proximal end or distal end of aflexible member, disposed over a portion of a flexible member, or withina passageway defined by a flexible member, and attached to the flexiblemember. Alternatively, a tubular member can have a proximal end attachedto the distal end of a shaft, a distal end attached to the proximal endof a shaft, a proximal end embedded within the material that forms ashaft, and/or a distal end embedded within the material that forms ashaft.

The third shaft 406 is attached to the tubular member 404 and has aproximal end 430, a distal end 432, and a body that defines a firstlumen 434 and a second lumen 436. Each of the first lumen 434 and thesecond lumen 436 extends from the proximal end 430 of the third shaft406 to the distal end 432 of the third shaft 406. The first lumen 434has a diameter that is greater than the diameter of the second lumen436. The first lumen 434 is sized and configured to receive a portion ofthe imaging device 218, data transfer cable 220, first optical fiber222, second optical fiber 224, irrigation tube 225, and/or safety wire410. The second lumen 436 is sized and configured to receive a portionof the wire member 216. Each of the first lumen 434 and second lumen 436defined by the third shaft 406 is in communication with the lumen 424defined by the tubular member 404. In the embodiment illustrated, thesecond lumen 436 defined by the third shaft 406 is disposed on a thirdshaft lengthwise axis that is parallel to the lengthwise axis 211 of thedeflectable catheter 208 and opposably positioned from an axis thatcontains the first lumen 236 defined by the first shaft 228 and thefirst lumen 416 defined by the second shaft 402 relative to thelengthwise axis 211. Thus, the second lumen 436 defined by the thirdshaft 406 is opposably positioned from the first lumen 416 defined bythe second shaft 402 relative to the lengthwise axis 211.

In the embodiment illustrated, the third shaft 406 is attached to thedistal end of the tubular member 404 such that a portion of the thirdshaft 406 is disposed within the lumen 424 defined by the tubular member404 and the distal end 422 of the tubular member 404 is disposed over aportion of the exterior surface of the third shaft 406. The tubularmember 404 is attached to the third shaft 406 using an adhesive.However, alternative embodiments can include a tubular member that isattached to the distal end of a shaft, or embedded within the materialthat forms a shaft.

The second flexible member 408 is attached to the distal end 432 of thethird shaft 406 and has a proximal end 440, a distal end 442, a length443, and defines a passageway 444. The length 443 of the second flexiblemember 408 extends from the proximal end 440 to the distal end 442 ofthe second flexible member 408. In the embodiment shown, the proximalend 440 is disposed over a portion of the exterior surface of the thirdshaft 406 and is attached to third shaft 406 using an adhesive. However,alternative embodiments can include a second flexible member that isattached to the distal end of the third shaft, or embedded within thematerial that forms the third shaft. The passageway 444 is incommunication with each of the first lumen 434 and second lumen 436defined by the third shaft 406.

The second shaft 402, tubular member 404, third shaft 406, and secondflexible member 408 can be formed of any suitable material and can befabricated using any suitable method of manufacture. Skilled artisanswill be able to select a suitable material to form a second shaft, atubular member, a third shaft, and a second flexible member and asuitable method of manufacture according to a particular embodimentbased on various considerations, including the desired flexibility ofthe elongate member. Example materials considered suitable to form asecond shaft, a tubular member, a third shaft, and a second flexibleinclude biocompatible materials, materials that can be madebiocompatible, metals such as stainless steel, titanium, nickel-titaniumalloy (e.g., Nitinol), polymers, Pebax, nylon, polyethylene,polyurethane, silicone, coiled materials, braided materials, and anyother material considered suitable for a particular application. Examplemethods of manufacture considered suitable to fabricate a second shaft,a tubular member, a third shaft, and a second flexible include extrusionprocesses, molding processes, and any other method considered suitablefor a particular application.

For example, the first shaft 228, second shaft 402, tubular member 404,and third shaft 406 can be formed of a first material and the firstflexible member 229 and second flexible member 408 can be formed of asecond material. The first material can be the same as, or differentthan, the second material. For example, the shaft of a deflectablecatheter can be formed of a material that has a first durometer hardnessand a flexible member of the deflectable catheter can be formed of amaterial that has a second durometer harness that is less than the firstdurometer harness. In the embodiment illustrated, each of the firstflexible member 229 and the second flexible member 408 is relativelymore flexible than the first shaft 228, second shaft 402, tubular member404, and third shaft 406.

Any suitable structure and/or material can be used to form a flexiblemember of an elongate member. Skilled artisans will be able to select asuitable structure and material to form a flexible member of an elongatemember according to a particular embodiment based on variousconsiderations, including the degree of curvature intended to beachieved when the deflectable catheter is in a second configuration. Inthe illustrated embodiment, each of the first flexible member 229 andthe second flexible member 408 is a stainless steel (e.g., medicalgrade) compression spring that defines a helical configuration thatextends from the proximal end of the flexible member to the distal endof the flexible member. The use of compression springs provides amechanism for returning the elongate member 212 to its first, straight,configuration after it has achieved a second, curved, configuration.Alternative structures and/or materials considered suitable to form aflexible member include helical cut nickel-titanium alloy (e.g.,Nitinol) segments, helical cut polymer segments, and any other structureand/or material considered suitable for a particular embodiment. Aflexible member included in a deflectable catheter can be formed of anymaterial capable of moving between first and second configurations andreturning to its first configuration when no force is being applied tothe flexible member.

In the illustrated embodiment, the cap 230 is attached to the distal end442 of the second flexible member 408 such that the wire member opening250 is opposably positioned from the first lumen 236 of the first shaft228 relative to the lengthwise axis 211 of the deflectable catheter 208.In the embodiment shown, the proximal end 245 of the cap 230 is disposedwithin the passageway 444 defined by the second flexible member 408 andis attached to second flexible member 408 using an adhesive. However,alternative embodiments can include a cap that is attached to the distalend of the second flexible member, or embedded within the material thatforms the second flexible member. In the embodiment illustrated, theshaft 247 of the cap 230 is entirely disposed within the passageway 444defined by the second flexible member 408 such that the flange 248 isadjacent to, and contacts, the distal end 242 of the second flexiblemember 408. Alternatively, the shaft of a cap can be partially disposedwithin a passageway defined by a flexible member such that the secondflexible member does not contact the flange of a cap.

In the illustrated embodiment, the distal end 432 of the third shaft 406is disposed from the proximal end 245 of the cap 230 a distance 437 asmeasured when the deflectable catheter 208 is in the straightconfiguration. In the embodiment illustrated, the distance 437 is equalto 20.0 millimeters. While the distal end 432 of the third shaft 406 hasbeen illustrated as disposed from the proximal end 245 of the cap 230 adistance 437, the distal end of a third shaft can be disposed anysuitable distance from the proximal end of a cap when a deflectablecatheter is in the straight configuration. Skilled artisans will be ableto select a suitable distance between the distal end of a third shaftand the proximal end of a cap according to a particular embodiment basedon various considerations, including the degree of curvature intended tobe accomplished when a deflectable catheter is in the secondconfiguration. Example distances considered suitable between the distalend of a third shaft and the proximal end of a cap include distancesequal to 20.0 millimeters, equal to about 20.0 millimeters, equal tobetween 10.0 millimeters and 30.0 millimeters, equal to between about10.0 millimeters and about 30.0 millimeters, and any other distanceconsidered suitable for a particular embodiment. For example, a firstembodiment of a deflectable catheter can have a first distance disposedbetween the distal end of a third shaft and the proximal end of a capand a second embodiment of a deflectable catheter can have a seconddistance disposed between the distal end of a third shaft and theproximal end of a cap that is less than the first distance. The firstembodiment can define a radius of curvature in the second configurationthat is less than a radius of curvature that the second embodiment candefine when it is in the second configuration. Thus, by increasing thedistance between the distal end of a shaft and the proximal end ofanother shaft, the radius of curvature can be decreased.

The second flexible member 408 has a length 443 that is greater than thedistance 437 between the distal end 432 of the third shaft 406 and theproximal end 245 of the cap 230. In the embodiment illustrated, thesecond flexible member has a length 443 that is equal to 27.0millimeters. However, alternative embodiments can include a secondflexible member that has a length that is less than, equal to, orsubstantially equal to, the distance between the distal end of a thirdshaft and the proximal end of a cap. While the second flexible member408 has been illustrated as having a particular length 443, a flexiblemember of a deflectable catheter can have any suitable length. Skilledartisans will be able to select a suitable length for a flexible memberof a deflectable catheter according to a particular embodiment based onvarious considerations, including the degree of curvature intended to beaccomplished when the deflectable catheter is in the secondconfiguration. Example lengths considered suitable for a flexible memberof a deflectable catheter include lengths equal to 27.0 millimeters,equal to about 27.0 millimeters, equal to between 17.0 millimeters and37.0 millimeters, equal to between about 17.0 millimeters and about 37.0millimeters, and any other length considered suitable for a particularembodiment.

While deflectable catheter 208 has been illustrated as including a firstshaft 228, a first flexible member 229, a second shaft 402, a tubularmember 404, a third shaft 406, and a second flexible member 408, adeflectable catheter can include any suitable number of shafts, flexiblemembers, and/or tubular members. Skilled artisans will be able to selecta suitable number of shafts, flexible members, and/or tubular members toinclude on a deflectable catheter according to a particular embodimentbased on various considerations, including the desired number of curvesintended to be defined by the deflectable catheter when in the secondconfiguration. Example number of shafts, flexible members, and/ortubular members considered suitable to include on a deflectable catheterinclude one, at least one, two, a plurality, and any other numberconsidered suitable for a particular embodiment.

While the second shaft 402 has been described as being adhesivelyattached to the first flexible member 229, the tubular member 404 hasbeen described as being adhesively attached to the second shaft 402, thethird shaft 406 has been described as being adhesively attached to thetubular member 404, the second flexible member 408 has been described asbeing adhesively attached to the third shaft 406, and the cap 230 hasbeen described as being adhesively attached to the second flexiblemember 408, a first component of an elongate member can be attached to asecond component of the elongate member using any suitable structurefor, or method of, attachment between two components. Skilled artisanswill be able to select a suitable structure for, or method of,attachment between a first component of an elongate member and a secondcomponent of the elongate member according to an embodiment based onvarious considerations, including the materials that form the firstcomponent and/or the second component. Example structures for, andmethods of, attachment between a first component of an elongate memberand a second component of the elongate member considered suitableinclude using an adhesive, welding, fusing (e.g., heat fusing), usingthreaded connections, and any other structure or method of attachmentconsidered suitable for a particular embodiment.

As shown in FIG. 15, the safety wire 410 has a first end 450 and asecond end 452. The first end 450 is attached to the proximal end 240 ofthe first flexible member 229 and the second end 452 is attached to thedistal end 442 of the second flexible member 408. In the embodimentillustrated, the safety wire 410 is soldered to the flexible members.Alternative embodiments can include a safety wire that is attached to ashaft in combination with, or independent of, attachment of the safetywire to the flexible member. While the safety wire 410 has beenillustrated as being attached to the proximal end 240 of the firstflexible member 229 and the distal end 442 of the second flexible member408, a safety wire can be attached to any suitable portion of a flexiblemember, shaft, and/or cap. Example locations considered suitable toattach a first end of a safety wire include at the distal end of a firstshaft, on the exterior surface of the first shaft between the proximalend and the distal end of a first shaft, on the interior surface of thefirst shaft between the proximal end and the distal end of a firstshaft, to the proximal end of a first flexible member, between theproximal end and the distal end of a first flexible member, at theproximal end of a second shaft, on the exterior surface of the secondshaft between the proximal end and the distal end of a second shaft, onthe interior surface of the second shaft between the proximal end andthe distal end of a second shaft, to the distal end of a first flexiblemember, and/or any other location considered suitable for a particularembodiment. Example locations considered suitable to attach a second endof a safety wire include at the distal end of a cap, on the exteriorsurface of a cap between the proximal end and the distal end of the cap,on the interior surface of a cap between the proximal end and the distalend of the cap, to the distal end of a second flexible member, betweenthe proximal end and the distal end of a second flexible member, at thedistal end of a third shaft, on the exterior surface of a third shaftbetween the proximal end and the distal end of the third shaft, on theinterior surface of a third shaft between the proximal end and thedistal end of the third shaft, to the proximal end of a second flexiblemember, and/or any other location considered suitable for a particularembodiment.

The safety wire 410 provides a mechanism for limiting, or substantiallylimiting, the amount of deformation (e.g., extension) that can beproduced on the elongate member 212 when tension is applied todeflectable catheter 208. While the safety wire 410 has been illustratedas attached to the proximal end 240 of the first flexible member 229 andthe distal end 442 of the second flexible member 408, otherconfigurations are considered suitable. Example configurationsconsidered suitable for the safety wire include attaching the first endof a safety wire to the proximal end of the first flexible member andthe second end of the safety wire to the distal end of the firstflexible member, attaching the first end of a safety wire to theproximal end of the first flexible member and the second end of thesafety wire to the proximal end of the second flexible member, attachingthe first end of a safety wire to the distal end of the first flexiblemember and the second end of the safety wire to the distal end of thesecond flexible member, attaching the first end of a safety wire to theproximal end of the second flexible member and the second end of thesafety wire to the distal end of the second flexible member, and anyother configuration considered suitable for a particular embodiment.Optionally, the safety wire 410 can be omitted from the deflectablecatheter 208. Optionally, any of the lumens and/or passageways describedherein can be sized and configured to receive a portion of a safety wirein addition to any other device, or component, described herein asdisposed within the lumen. Optionally, more than one (e.g., two, aplurality) safety wire can be included in a deflectable catheter. Forexample, a first safety wire can extend along the length of a firstflexible member and a second safety wire can extend along the length ofa second flexible member. The first safety wire can have a first endattached to the proximal end of the first flexible member, and/or thedistal end of a first shaft, and a second end attached to the distal endof the first flexible member, and/or the proximal end of a second shaft.The second safety wire can have a first end attached to the proximal endof the second flexible member, and/or the distal end of a third shaft,and a second end attached to the distal end of the second flexiblemember, and/or the proximal end of a fourth shaft, tubular member, orcap.

The safety wire 410 can have any suitable diameter and be formed of anysuitable material, and skilled artisans will be able to select asuitable diameter and material for a safety wire according to aparticular embodiment based on various considerations, including thedegree of tension desired to be applicable to a deflectable catheter.Example materials considered suitable to form a safety wire includebiocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nickel-titanium alloy (e.g.,Nitinol), polymers, Pebax, nylon, polyethylene, polyurethane, silicone,coiled materials, braided materials, and any other material consideredsuitable for a particular application. The safety wire can have anysuitable structural configuration. Example structural configurationsconsidered suitable for a safety wire include cross-sectionalconfigurations that are round, rectangular (e.g., flat wire), and anyother structural configuration considered suitable for a particularembodiment.

While the safety wire 410 has been illustrated as extending through thepassageway 244 defined by the first flexible member 229, through thefirst lumen 416 defined by the second shaft 402, through the lumen 424defined by the tubular member 410, through the first lumen 434 definedby the third shaft 406, and through the passageway 444 defined by thesecond flexible member 408, a flexible member can extend through anysuitable lumen and/or passageway described herein. For example, in analternative embodiment, a safety wire can extend through the passagewaydefined by a first flexible member, through the second lumen defined bya second shaft, through the lumen defined by a tubular member, throughthe second lumen defined by a third shaft, and through the passagewaydefined by a second flexible member.

While the safety wire 410 has been described as being soldered to eachof the first flexible member 229 and the second flexible member 408, asafety wire can be attached to any portion of an elongate member usingany suitable structure for, or method of, attachment between twocomponents. Skilled artisans will be able to select a suitable structurefor, or method of, attachment between a safety wire and a component ofan elongate member according to an embodiment based on variousconsiderations, including the materials that form the safety wire andthe component to which the safety wire is intended to be attached.Example structures for, and methods of, attachment between a safety wireand a component of an elongate member considered suitable include usingan adhesive, welding, fusing (e.g., heat fusing), using threadedconnections, and any other structure or method of attachment consideredsuitable for a particular embodiment.

In the illustrated embodiment, when the deflectable catheter 208 is inthe first, straight configuration, the first lumen 236 defined by thefirst shaft 228 and the first lumen 416 defined by the second shaft 402are disposed on a first plane that contains the lengthwise axis 211 ofthe deflectable catheter 408. When the deflectable catheter 208 is inthe first, straight configuration, each of the second lumen 436 definedby the third shaft 406, the wire member second end 368, and the wiremember opening 250 defined by the cap 230 is disposed on a second planethat contains the lengthwise axis 211 of the deflectable catheter 208.In the illustrated embodiment, the first plane and the second plane arecoplanar and the first lumen 236 defined by the first shaft 228 and thefirst lumen 416 defined by the second shaft 402 are opposably positionedfrom the second lumen 436 defined by the third shaft 406, the wiremember second end 368, and the wire member opening 250 defined by thecap 230 relative to a plane that contains the lengthwise axis 211 of thedeflectable catheter 208 and that is disposed orthogonal to the firstplane and the second plane. Thus, the first lumen 236 defined by thefirst shaft 228 and the first lumen 416 defined by the second shaft 402are opposably positioned from the second lumen 436 defined by the thirdshaft 406, the wire member second end 368, and the wire member opening250 defined by the cap 230 relative to the lengthwise axis 211.

While the first plane that contains the first lumen 236 defined by thefirst shaft 228 and the first lumen 416 defined by the second shaft 402and the second plane that contains the second lumen 436 defined by thethird shaft 406, the wire member second end 368, and the wire memberopening 250 defined by the cap 230 have been described as coplanar, thefirst plane and second plane can be positioned at any suitable anglerelative to one another and include any suitable feature describedherein. Skilled artisans will be able to select a suitable angle toposition a first plane that contains one or more features of an elongatemember relative to a second plane that includes one or more features ofan elongate member according to a particular embodiment based on variousconsiderations, including the structural arrangement of the bodilypassage within which a deflectable catheter is intended to be used.Example angles considered suitable to position a first plane (e.g., thatcontains the first lumen 236, distal end of the first lumen 236, firstlumen 416 defined by the second shaft 402, and/or distal end of thefirst lumen 416 defined by the second shaft 402) and a second plane(e.g., that contains the second lumen 436 defined by the third shaft406, the distal end of the second lumen 436 defined by the third shaft406, the wire member second end 368, and/or the wire member opening 250defined by the cap 230) include positioning the first plane and thesecond plane such that they are coplanar, orthogonal to one another, orsuch that the angle disposed between the first plane and the secondplane is an angle equal to about 45 degrees, an angle between about 1degree and about 90 degrees, an angle about 90 degrees, an angle betweenabout 90 degrees and about 180 degrees, an angle between about 180degrees and about 270 degrees, an angle between about 270 degrees andabout 360 degrees, an angle equal to, substantially equal to, greatthan, or less than, 45 degrees, 90 degrees, 180 degrees, 270 degrees,and any other angle considered suitable for a particular application.

The first end of wire member 216 is attached to the actuator 262 andextends from the first end of the wire member 216 through the firstlumen 236 defined by the first shaft 228, through the passageway 244defined by the first flexible member 229, through the first lumen 416defined by the second shaft 402, through the lumen 424 defined by thetubular member 404 such that is passes through a plane that contains thelengthwise axis 211 of the deflectable catheter 208, through the secondlumen 436 defined by the third shaft 406, through the passageway 444defined by the second flexible member 408, and is attached to cap 230within wire member opening 250 (e.g., using an adhesive, welding).However, other methods of attachment, such as those described herein,are considered suitable. In the illustrated embodiment, the wire member216 is disposed between the second flexible member 408 and the exteriorsurface of the cap 230 from the proximal end 245 of the cap 230 to theflange 248.

Each of the data transfer cable 220, first optical fiber 222, secondoptical fiber 224, and irrigation tube 225 extends from the handle 214through the second lumen 238 of the first shaft 228, the passageway 244defined by the first flexible member 229, the second lumen 418 definedby the second shaft 402, the lumen 424 defined by the tubular member404, the first lumen 434 defined by the third shaft 406, the passageway444 defined by the second flexible member 408 and is attached to theimaging device 218 or cap 230, as described herein. The imaging device218 is attached to the data transfer cable 220, disposed within thepassageway 249 defined by the cap 230, and is attached to the cap 230(e.g., using adhesive, welding). The first optical fiber 222 is disposedbetween the second flexible member 408 and the exterior surface of thecap 230 from the proximal end 245 of the cap 230 to the first opticalfiber opening 251 and is attached to the cap 230 (e.g., using adhesive).The second optical fiber 224 is disposed between the second flexiblemember 408 and the exterior surface of the cap 230 from the proximal end245 of the cap 230 to the second optical fiber opening 252 and isattached to the cap 230 (e.g., using adhesive). The irrigation tube 225is disposed between the second flexible member 408 and the exteriorsurface of the cap 230 from the proximal end 245 of the cap 230 to theirrigation tube opening 253 and is attached to the cap 230 (e.g., usingadhesive) such that the second end 192 of the irrigation tube 225 isdirected toward the imaging device 218.

While each of the wire member 216, first optical fiber 222, secondoptical fiber 224, and irrigation tube 225 has been illustrated anddescribed as disposed between the interior surface of the secondflexible member 408 and the exterior surface of the cap 230, otherstructural arrangements are considered suitable. For example,alternative embodiments can include a tubular member that is attached tothe shaft of a cap such that the exterior surface of the tubular memberis attached to a second flexible member and each of the wire member,first optical fiber, second optical fiber, and irrigation tube isdisposed within the tubular member, disposed between the interiorsurface of the tubular member and the shaft of the cap, and extend to anopening defined by the flange of the cap, as described herein.Alternatively, a dual lumen shaft can be attached to the shaft of a capsuch that the exterior surface of the dual lumen shaft is attached to asecond flexible member and the wire member is disposed in a first lumendefined by the dual lumen shaft and each of the first optical fiber,second optical fiber, and irrigation tube is disposed in a second lumendefined by the dual lumen shaft. The dual lumen shaft can be attached tothe cap such that the lumen in which the wire member is disposed iscoaxial with the wire member opening defined by the cap. This isillustrated in FIG. 22. Each of the first optical fiber, second opticalfiber, and irrigation tube extends through the second lumen defined bythe dual lumen shaft and is disposed between the interior surface of thesecond lumen defined by the dual lumen shaft and the exterior surface ofthe shaft of the cap, and extend to an opening defined by the flange ofthe cap, as described herein.

In use, movement of actuator 262 away from elongate member distal end227, as shown by arrow 370 in FIG. 10, from the actuator first position,as shown in FIG. 10, in a proximal direction to the actuator secondposition (not shown) causes the wire member 216 to move in a proximaldirection such that wire member first end (not shown) advances away fromthe distal end 227 of the elongate member 212. This creates tension inthe wire member 216 that results in movement of wire member second end368 and elongate member 212 such that elongate member 212 moves from astraight configuration, as shown in FIG. 10, to a curved configuration,as shown in FIG. 16, in which elongate member 212 defines a first curve372 at a first radius of curvature 374 and a second curve 372′ at asecond radius of curvature 374′. In the embodiment illustrated, thefirst radius of curvature 374 is greater than the second radius ofcurvature 374′ such that the first curve 372 provides less deflectionthan the second curve 372′ when the elongate member 212 is in thesecond, curved, configuration. Movement of actuator 262 toward elongatemember distal end 228, in a direction opposite that of arrow 370,reduces, or eliminates, tension in wire member 216 and results inelongate member 212 returning to the straight configuration. Thus, whenactuator 262 is in the actuator first position, elongate member 212 isin the straight configuration and when actuator 262 is in the actuatorsecond position, elongate member 212 is in the curved configuration.

When elongate member 212 is in the curved configuration, the portion ofelongate member 212 disposed distal to the first curve 374 is disposedat an angle (e.g., less than 180 degrees) to the portion of the elongatemember 212 disposed proximal to the first curve 374 relative to an axisthat is parallel to the lengthwise axis 211 of the deflectable catheter208. In addition, when elongate member 212 is in the curvedconfiguration, the portion of the elongate member 212 disposed distal tothe second curve 374′ is disposed at an angle (e.g., less than 270degrees) to the portion of the elongate member 212 disposed proximal tothe second curve 374′ relative to an axis that is parallel to thelengthwise axis 211 of the deflectable catheter 208. The portion of anelongate member disposed distal to a curve can be disposed at anysuitable angle to the portion of the elongate member disposed proximalto the curve, and skilled artisans will be able to select a suitableangle according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example angles considered suitable to define between a portion of anelongate member disposed distal to a curve and a portion of an elongatemember disposed proximal to the curve include angles between about 0degrees and 180 degrees, about 45 degrees, about 90 degrees, about 120degrees, equal to, substantially equal to, greater than, or less than,45 degrees, 90 degrees, 120 degrees, and any other angle consideredsuitable for a particular application.

The radii of curvature 374, 374′ defined by the elongate member 212 canvary and be based upon at least the material(s) that forms the elongatemember 212, the location of the actuator second position, the length ofelongate member 212, the length of wire member 216, the axial length ofactuator opening as it relates to the length of elongate member 212, thedistance between the distal end 234 of the first shaft 228 and theproximal end 412 of the second shaft 402, and/or the distance betweenthe distal end 432 of the third shaft 406 and the proximal end 245 ofthe cap 230. For example, by increasing the distance between the distalend of a first shaft and the proximal end of a second shaft and/or thedistance between the distal end of a third shaft and the proximal end ofa cap, the amount of deflection can be increased and radius of curvaturecan be reduced. Movement of an elongate member 212 between a straightconfiguration and a curved configuration allows the deflectable catheter208 to be advanced through tortuous bodily passages, such as airways,sinus cavities, and/or sinus passages. In addition, movement between astraight and curved configuration allows for the elongate member 212 tobe manipulated such that distal end 227 of the elongate member 212 canbe positioned in various configurations to view various aspects of abodily passage (e.g., during the performance of a sleep study).

Various methods are described herein. While the methods described hereinare shown and described as a series of acts, it is to be understood andappreciated that the methods are not limited by the order of acts, assome acts may, in accordance with these methods, occur in differentorders, and/or concurrently with other acts described herein.

FIG. 17 is a flowchart representation of an exemplary method 500 ofvisualizing a bodily passage.

A step 502 comprises introducing a deflectable catheter that has adeflectable catheter proximal end and a deflectable catheter distal endinto a bodily passage such that the deflectable catheter distal end isdisposed in the bodily passage. The deflectable catheter comprises anelongate member, an actuator, and a wire member. Another step 504comprises advancing the actuator from an actuator first position to anactuator second position to define a curve along the length of theelongate member within the bodily passage. Another step 506 comprisesallowing an interval of time to pass. Another step 508 comprisesadvancing the actuator from the actuator second position to the actuatorfirst position. Another step 510 comprises removing the deflectablecatheter from the bodily passage.

Step 502 can be accomplished by applying a proximal and/or distallydirected force on any suitable portion of a deflectable catheter suchthat it is introduced into a bodily passage.

Step 502 can be accomplished using any suitable deflectable catheter ordeflectable catheter system, and skilled artisans will be able to selecta suitable deflectable catheter or deflectable catheter system accordingto a particular embodiment based on various considerations, includingthe procedure intended to be performed. Example deflectable cathetersconsidered suitable to perform method 500 include deflectable catheter8, deflectable catheter 208, and any other deflectable catheterconsidered suitable for a particular embodiment. Example deflectablecatheter systems considered suitable to perform method 500 includedeflectable catheter system 602, and any other deflectable cathetersystem considered suitable for a particular embodiment. An exampledeflectable catheter that can be used to accomplish the methods, steps,optional steps, and/or alternative steps described herein is deflectablecatheter 208 and is illustrated and described with respect to FIGS. 10,11, 12, 13, 14, 15, and 16.

Furthermore, while method 500 has been described as introducing adeflectable catheter into a bodily passage, it is considered suitable todeploy a deflectable catheter into any suitable bodily passage. Skilledartisans will be able to select a suitable bodily passage to deploy adeflectable catheter according to a particular embodiment based onvarious considerations, including the procedure intended to beperformed. Example bodily passages considered suitable include, but arenot limited to, sinus passages, airways, sinus cavities, and any otherbodily passage considered suitable for a particular application.

Step 504 can be accomplished by applying a proximally directed force onthe actuator such that it moves from the actuator first position to theactuator second position. The application of a proximally directed forceon the actuator axially advances the wire member in the proximaldirection such that the elongate member moves from a straight, orsubstantially straight, configuration, to a curved configuration inwhich elongate member defines one or more curves along its length.Alternatively, step 504 can comprise advancing the actuator from theactuator first position to a position between the actuator firstposition and the actuator second position. Alternatively, step 504 canbe completed such that the elongate member defines a curve outside ofthe bodily passage.

Step 506 can be accomplished by completing step 502 and/or step 504 andwaiting for an interval of time to pass before completing step 508and/or step 510. Any suitable interval of time is considered suitable,and skilled artisans will be able to select a suitable interval of timeaccording to a particular embodiment based on various considerations,including the procedure being performed. Example intervals of timeconsidered suitable include, but are not limited to, allowing one ormore seconds to pass, one or more minutes to pass, one or more hours topass, one or more days to pass, and any other interval of timeconsidered suitable for a particular application.

An optional step comprises adjusting the position of the elongate memberdistal end within the bodily passage. This can be accomplished byapplying a force on the actuator such that it moves between the actuatorfirst position and actuator second position and/or applying a force onthe deflectable catheter such that is advanced into or withdrawn fromthe bodily passage.

Step 508 can be accomplished by applying a distally directed force onthe actuator such that it moves from the actuator first position to theactuator second position. The application of a distally directed forceon the actuator axially advances the wire member in the distal directionsuch that the elongate member moves from a curved configuration in whichelongate member defines one or more curves along its length to astraight, or substantially straight, configuration. Alternatively, step508 can comprise advancing the actuator from the actuator secondposition, or a position between the actuator second position and theactuator first position, to a position between the actuator firstposition and the actuator second position. Optionally, step 508 can beomitted from method 500.

Step 510 can be accomplished by placing a proximally and/or distallydirected force on any suitable portion of a deflectable catheter suchthat it is withdrawn from the bodily passage.

An optional step comprises confirming placement of the elongate memberand/or that the elongate member defines one or more curves along itslength. This optional step can be accomplished using any suitablestructure or method of visualization, and skilled artisans will be ableto select a suitable structure or method to visualize an elongate memberaccording to a particular embodiment based on various considerations,such as the desired bodily passage within which a deflectable catheteris intended to be deployed. Example structures and methods ofvisualization include, but are not limited, using direct visualization,fluoroscopy, a scope, transcutaneously, taking an x-ray, and any othermethod considered suitable for a particular application.

Another optional step comprises performing treatment. This optional stepcan be completed using any suitable device, system, or component. Forexample, this optional step can be completed by performing a sleep studyon a patient. Alternatively, or in combination with performing a sleepstudy, this optional step can be completed by introducing a fluid intothe irrigation tube to flush a bodily passage, sinus passage, airway,and/or sinus cavity. Alternatively, or in combination with performing asleep study, this optional step can be completed by applying suction tothe irrigation tube to withdraw material within a bodily passage, sinuspassage, airway, and/or sinus cavity. Another optional step comprisescleaning the imaging device. This optional step can be completed byintroducing a fluid into the irrigation tube until the imaging device isclean.

While various steps, alternative steps, and optional steps have beendescribed above with respect to visualizing a bodily passage, thesesteps, alternative steps, and optional steps can be included in,accomplished concurrently with, and/or accomplished in the alternativeto, the method, steps, alternative steps, and/or optional stepsdescribed below with respect to method 1500.

FIGS. 18, 19, and 20, illustrate a deflectable catheter system 602 thatcomprises a proximal housing 603, a tubular member 604, and adeflectable catheter 608. The tubular member 604 is attached to theproximal housing 603 and the deflectable catheter 608. Deflectablecatheter 608 is similar to the deflectable catheter 208 illustrated inFIGS. 10, 11, 12, 13, 14, 15, and 16, and described above, except asdetailed below. Reference numbers in FIGS. 18, 19, and 20 refer to thesame structural element or feature referenced by the same number inFIGS. 10, 11, 12, 13, 14, 15, and 16, offset by 400. Thus, thedeflectable catheter 608 includes an elongate member 612, a handle 614,a wire member 616, an imaging device 618, a data transfer cable 620, afirst optical fiber 622, a second optical fiber 624, and an irrigationtube 625.

While deflectable catheter system 602 has been illustrated as includingdeflectable catheter 608, a deflectable catheter system can include anysuitable deflectable catheter, and skilled artisans will be able toselect a suitable deflectable catheter to include in a deflectablecatheter system according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example deflectable catheters considered suitable to include in adeflectable catheter system include deflectable catheter 8, deflectablecatheter 208, and any other deflectable catheter considered suitable fora particular embodiment.

In the illustrated embodiment, the deflectable catheter system 602includes a first set of straps 605′, a second set of straps 605″, asecond data transfer cable 620′, and a third data transfer cable 620″.In addition, the handle 614 defines the passageway 702″ on the proximalend of the handle 614. The passageway 702″ is sized and configured toreceive a portion of tubular member 604. While, the passageway 702″ hasbeen illustrated at the proximal end of the handle 614, a passagewaydefined by a handle can be defined at any suitable location on thehandle, such as on a side, at the distal end, or at any other locationconsidered suitable for a particular embodiment.

The proximal housing 603 has a proximal end 860, a distal end 862, and abody 864 that defines a chamber 866, an irrigation port 868, a firstopening 870, and a second opening 872. The irrigation port 868 has apassageway 867 that is in communication with the chamber 866 and an end873 that has a connector. The end 873 of the irrigation port 868 caninclude any suitable connector and/or adapter capable of attaching oneor more devices to the irrigation port 868. Skilled artisans will beable to select a suitable connector and/or adapter to include on the endof an irrigation port according to a particular embodiment based onvarious considerations, including the materials that form the irrigationport. Example connectors and/or adapters considered suitable to includeon an irrigation port include threaded connectors, Tuohy Borst adapters,luer lock connectors, and any other connector and/or adapter consideredsuitable for a particular embodiment.

Each of the first opening 870 and second opening 872 extends through thebody 864 and provides access to the chamber 866. The first opening 870is sized and configured to receive a portion of tubular member 604 andthe second opening 872 is sized and configured to receive a portion ofanother device (e.g., communications device, HDMI cable, communicationcable, power cable) and allow the device to pass through second opening872 such that it can be attached to a control board (e.g., control board664), or another device (e.g., data transfer cable). The proximalhousing 603 can be attached at any suitable location during use. Forexample, the proximal housing 603 can be attached to a patient, to thebed of a patient, to a medical cart, or any other location.

The tubular member 604 has a proximal end 874, a distal end 876, and abody 878 that defines a lumen 880 that extends from the proximal end 874to the distal end 876. The tubular member 604 is attached to theproximal housing 603 such that the lumen 880 defined by the tubularmember 604 is in communication with the chamber 866 defined by thehousing 603. The tubular member 604 is attached to the handle 614 suchthat the lumen 880 defined by the tubular member 604 is in communicationwith the housing chamber (not shown). The tubular member 604 can beattached to the proximal housing 603 and the handle 614 using anysuitable method of attachment, such as adhesive. While the tubularmember 604 has been described as being adhesively attached to theproximal housing 603 and the handle 614, a tubular member can beattached to a housing and a handle using any suitable structure for, ormethod of, attachment between two components. Skilled artisans will beable to select a suitable structure for, or method of, attachmentbetween a tubular member and a housing and a handle according to anembodiment based on various considerations, including the materials thatform the tubular member, housing, and/or handle. Example structures for,and methods of, attachment between a tubular member and a housing andtubular member and a handle considered suitable include using anadhesive, welding, fusing (e.g., heat fusing), using threadedconnections, connectors and/or adapters, such as threaded connectors,Tuohy Borst adapters, luer lock connectors, and any other structure ormethod of attachment considered suitable for a particular embodiment.

A tubular member 604 can have any suitable length and outside diameter,and skilled artisans will be able to select a suitable length andoutside diameter for a tubular member according to a particularembodiment based on various considerations, including the location atwhich a proximal housing is intended to be attached during use. Examplelengths considered suitable for a tubular member include lengths between100 centimeters and 300 centimeters, lengths between about 100centimeters and 300 centimeters, lengths equal to, substantially equalto, less than, or greater than, 100 centimeters, 300 centimeters, andany other length considered suitable for a particular embodiment.Example outside diameters considered suitable for a tubular memberinclude outside diameters between 2.0 millimeters and 6.0 millimeters,between about 2.0 millimeters and about 6.0 millimeters, outsidediameters equal to, substantially equal to, less than, or greater than,2.0 millimeters, 6.0 millimeters, and any other outside diameterconsidered suitable for a particular embodiment.

In the embodiment illustrated, the first end of the irrigation tube 625is attached to the proximal housing 603 such that lumen 794 defined bythe irrigation tube 625 is in communication with the lumen 867 definedby the irrigation port 868. The irrigation tube 625 extends through thelumen 880 defined by the tubular member 604, through the handle 614,through the elongate member 612, and is attached to the cap 630, asdescribed herein. Thus, fluid can be introduced through the irrigationport 868 and through the irrigation tube 625.

The second data transfer cable 620′ has a first end attached to theproximal end 860 of the proximal housing 603, extends through thetubular member 604, and has a second end attached to the control boardhoused within handle 614. The second data transfer cable 620′ isattached to the control board such that data and/or power can betransmitted between the second data transfer cable and the controlboard. Thus, the second data transfer cable 620′ is in signalcommunication with the control board. The third data transfer cable 620″has a first end 888 attached to the first end of the second datatransfer cable 620′ and a second end (not shown) that can be attached toany suitable device, component, and/or system. Thus, the third datatransfer cable 620″ is in signal communication with the second datatransfer cable 620′ and another device. For example, the second end ofthe third data transfer cable 620″ can be attached to a control unit,such as the control units described in U.S. Nonprovisional applicationSer. No. 14/191,535, filed Feb. 27, 2014, and entitled Medical Devices,Systems, and Methods for the Visualization and Treatment of BodilyPassages. Each of the second data transfer cable 620′ and/or third datatransfer cable 620″ can comprise any suitable device capable oftransmitting data and/or power, such as those described herein (e.g.,HDMI cable, communication cable, power cable).

While the proximal housing 603 has been illustrated as having aparticular structural arrangement, a proximal housing can have anysuitable structural arrangement, and skilled artisans will be able toselect a suitable structural arrangement for a proximal housingaccording to a particular embodiment based on various considerations,including the devices and/or components that are housed within theproximal housing. For example, a proximal housing can have any of thefeatures described with respect to handle 14, handle 214, can define afirst and/or second opening on the side of the proximal housing, and/orcan be sized and configured to house a control board and/or any of theother devices, components, and/or features described with respect tohandle 14 and/or handle 214, as described in more detail herein.

The first set of straps 605′ provides a mechanism for attaching theproximal housing 603 to another structure (e.g., patient, bed of apatient, medical cart) and the second set of straps 605″ provides amechanism for attaching the handle 614 to another structure (e.g.,patient, bed of patient, medical cart). The first set of straps 605′ isattached to the proximal housing 603 and is sized and configured toattach the proximal housing 603 the bed of a patient. The second set ofstraps 605″ is attached to the handle 614 and is sized and configured toattach the handle 614 to the bicep of a patient, or other suitablestructure. Each strap of the plurality of straps can comprise anysuitable length and/or structure capable of providing releasableattachment between the device on which the strap is attached and anotherstructure. For example, a pair of mating straps can include hook andloop fasteners to provide releasable attachment. However, other forms ofreleasable attachment are considered suitable, such as using adhesive,or any other form of attachment considered suitable for a particularembodiment.

The deflectable catheter system 602 illustrated in FIGS. 18, 19, and 20provides a mechanism for positioning the proximal housing 603 at a firstlocation relative to a patient and positioning the handle 614 at asecond location relative to a patient that is different than the firstlocation. This configuration allows for deflection of the elongatemember to be accomplished at the second location and irrigation to beaccomplished at the first location.

FIG. 21 illustrates a cross-sectional view of another deflectablecatheter system 902 that comprises a proximal housing attached to adeflectable catheter. The cross-sectional view has been taken along thelength of the tubular member of the system that is disposed between theproximal housing and the handle (e.g., tubular member 604). Thedeflectable catheter system 902 is similar to the deflectable cathetersystem 602 illustrated in FIGS. 18, 19 and 20, and described above,except as detailed below. Reference numbers in FIG. 21 refer to the samestructural element or feature referenced by the same number in FIGS. 18,19, 20, and 21, offset by 300.

In the illustrated embodiment, the proximal housing houses the controlboard such that each of the data transfer cable 920, first light fiber922, second light fiber 924, and the irrigation tube 925 extends fromthe chamber defined by the proximal housing, through the tubular member904, through the handle, through the elongate member and is attached tothe cap, as described herein.

FIG. 22 illustrates another deflectable catheter 1208. The deflectablecatheter 1208 is similar to the deflectable catheter 208 illustrated inFIGS. 10, 11, 12, 13, 14, 15, and 16, and described above, except asdetailed below. Reference numbers in FIG. 22 refers to the samestructural element or feature referenced by the same number in FIGS. 10,11, 12, 13, 14, 15, and 16, offset by 1000. The handle, imaging device,data transfer cable, first optical fiber, second optical fiber, andirrigation tube have been omitted from FIG. 22 for clarity. Thus, thedeflectable catheter 1208 includes an elongate member 1212 and a wiremember 1216.

In the illustrated embodiment, the elongate member 1212 has a proximalend (not shown), a distal end 1227, a first shaft 1228, a first flexiblemember 1229, a second shaft 1402, a tubular member 1404, a third shaft1406, a second flexible member 1408, a safety wire 1410, a cap 1230, anda fourth shaft 1460.

In the illustrated embodiment, the fourth shaft 1460 is attached to thesecond flexible member 1408 and has a proximal end 1462, a distal end1464, and a body that defines a first lumen 1466 and a second lumen1468. Each of the first lumen 1466 and the second lumen 1468 extendsfrom the proximal end 1462 of the fourth shaft 1460 to the distal end1464 of the fourth shaft 1460. The first lumen 1466 has a diameter thatis greater than the diameter of the second lumen 1468. The first lumen1466 is sized and configured to receive a portion of the imaging device,data transfer cable, first optical fiber, second optical fiber,irrigation tube, safety wire, and/or cap 1230. The second lumen 1468 issized and configured to receive a portion of the wire member 1216. Eachof the first lumen 1466 and second lumen 1468 defined by the fourthshaft 1460 is in communication with the passageway 1444 defined by thesecond flexible member 1408. In the embodiment illustrated, the secondlumen 1468 defined by the fourth shaft 1460 is disposed on an axis thatis parallel to the lengthwise axis 1211 of the deflectable catheter1208, is coaxial with an axis that extends through the second lumen 1436defined by the third shaft 1406 and an axis that that extends throughthe wire member opening 1250, and is opposably positioned from an axisthat extends through the first lumen 1236 defined by the first shaft1228 and the first lumen 1416 defined by the second shaft 1402 relativeto the lengthwise axis 1211. Thus, the second lumen 1468 defined by thefourth shaft 1460 is opposably positioned from the first lumen 1416defined by the second shaft 1402 relative to the lengthwise axis 1211.

The cap 1230 is disposed within the first lumen 1466 defined by thefourth shaft 1460 and a portion of the exterior surface of the cap 1230is attached to a portion of the interior surface of the fourth shaft1460. In addition, the second flexible member 1408 is attached to aportion of the exterior surface of the fourth shaft 1460. The cap 1230is attached to the fourth shaft 1460 using adhesive and the secondflexible member 1408 is attached to the fourth shaft 1460 usingadhesive.

While adhesive has been described as providing attachment between thecap 1230 and the fourth shaft 1460 and between the fourth shaft 1460 andthe second flexible member 1408, a cap can be attached to a shaft and aflexible member can be attached to a shaft using any suitable structurefor, or method of, attachment between two components. Skilled artisanswill be able to select a suitable structure for, or method of,attachment between a cap and a shaft and between a flexible member and ashaft according to an embodiment based on various considerations,including the materials that form the shaft, flexible member, and/orcap. Example structures for, and methods of, attachment between a capand a shaft and between a shaft and a flexible member consideredsuitable include using an adhesive, welding, fusing (e.g., heat fusing),using threaded connections, and any other structure or method ofattachment considered suitable for a particular embodiment.

The wire member 1216 is disposed in, and extends through, the secondlumen 1468 defined by the fourth shaft 1460 and is attached to the cap1230 within wire member opening 1250. A portion of each of the firstoptical fiber, second optical fiber, and irrigation tube is disposedwithin the first lumen 1466 defined by the fourth shaft 1460 between theinterior surface of the first lumen 1466 and the exterior surface of theshaft of the cap 1230. Each of the first optical fiber, second opticalfiber, and irrigation tube extends through the first lumen 1466 definedby the fourth shaft 1460 to an opening defined by the flange of the cap1230, as described herein.

FIG. 23 is a flowchart representation of an exemplary method 1500 ofvisualizing an airway using a deflectable catheter system.

A step 1502 comprises attaching a proximal housing to a first component.Another step 1504 comprises attaching the handle of a deflectablecatheter to a second component that is different than the firstcomponent. The deflectable catheter has a proximal end and a distal endand comprises an elongate member, a handle, a wire member, an imagingdevice, a data transfer cable, a first optical fiber, a second opticalfiber, and an irrigation tube. Another step 1506 comprises introducingthe deflectable catheter into an airway such that the deflectablecatheter distal end is disposed in the airway. Another step 1508comprises advancing the deflectable catheter into the airway. Anotherstep 1510 comprises advancing the actuator from an actuator firstposition to an actuator second position to define a curve along thelength of the elongate member within the airway. Another step 1512obtaining one or more images. Another step 1514 comprises allowing aninterval of time to pass. Another step 1516 comprises advancing theactuator from the actuator second position to the actuator firstposition. Another step 1518 comprises removing the deflectable catheterfrom the airway. Another step 1520 comprises removing the proximalhousing from the first component. Another step 1522 comprises removingthe handle of the deflectable catheter from the second component.

Step 1502 can be accomplished using any suitable deflectable cathetersystem, and skilled artisans will be able to select a suitabledeflectable catheter according to a particular embodiment based onvarious considerations, including the procedure intended to beperformed. Example deflectable catheters systems considered suitable toperform method 1500 include deflectable catheter system 602, and anyother deflectable catheter system considered suitable for a particularembodiment. An example deflectable catheter system that can be used toaccomplish the methods, steps, optional steps, and/or alternative stepsdescribed herein is deflectable catheter system 602 and is illustratedand described with respect to FIGS. 18, 19, and 20.

Furthermore, while method 1500 has been described as introducing adeflectable catheter of a deflectable catheter system into an airway, itis considered suitable to deploy a deflectable catheter of a deflectablecatheter system into any suitable bodily passage. Skilled artisans willbe able to select a suitable bodily passage to deploy a deflectablecatheter according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example bodily passages considered suitable include, but are not limitedto, sinus passages, airways, sinus cavities, and any other bodilypassage considered suitable for a particular application.

Step 1502 can be accomplished by attaching a first attachment member(e.g., the first set of straps) to a first component. The firstcomponent can comprise any suitable structure that is positioned at afirst location and is capable of receiving a portion of a firstattachment member such that the proximal housing can be releasablyattached to the first component. Example structures considered suitableto releasably attach a proximal housing include a patient, a patient'sarm, a patient's leg, a patient's bed, a medical cart, and any otherstructure considered suitable for a particular embodiment.

Step 1504 can be accomplished by attaching a second attachment member(e.g., second set of straps) to a second component. The second componentcan comprise any suitable structure that is positioned at a secondlocation that is different than the first location and that is capableof receiving a portion of a second attachment member such that thehandle of the deflectable catheter can be releasably attached to thesecond component. Example structures considered suitable to releasablyattach the handle of a deflectable catheter include a patient, apatient's arm, a patient's leg, a patient's bed, a medical cart, and anyother structure considered suitable for a particular embodiment.

Step 1506 can be accomplished by applying a proximal and/or distallydirected force on any suitable portion of a deflectable catheter suchthat it is introduced into an airway.

Step 1508 can be accomplished by applying a distally directed force onany suitable portion of the deflectable catheter such that it advancesinto the airway.

Step 1510 can be accomplished by applying a proximally directed force onthe actuator such that it moves from the actuator first position to theactuator second position. The application of a proximally directed forceon the actuator axially advances the wire member in the proximaldirection such that the elongate member moves from a straight, orsubstantially straight, configuration, to a curved configuration inwhich elongate member defines one or more curves along its length andwithin the airway. Alternatively, step 1510 can comprise advancing theactuator from the actuator first position to a position between theactuator first position and the actuator second position. Alternatively,step 1510 can be completed such that the elongate member defines a curveoutside of the airway.

Step 1512 can be accomplished using any suitable method of obtaining oneor more images of an airway, or bodily passage. For example, an imagingdevice included on a deflectable catheter can be activated such that oneor more images are sent to a control board, or other device via wireddata transfer cable or wirelessly, as described herein.

An optional step comprises attaching the deflectable catheter to asecond device, such as a computer, network, storage device, computerreadable storage medium, or any other suitable device, such as thosedescribed herein. Another optional step comprises storing the one ormore images obtained by the imaging device relative to an interval oftime. Another optional step comprises displaying the one or more imagesobtained by the imaging device.

Step 1514 can be accomplished by completing steps 1506, 1508, 1510,and/or step 1512 and waiting for an interval of time to pass beforecompleting step 1516, 1518, 1520, and/or step 1522. Any suitableinterval of time is considered suitable, and skilled artisans will beable to select a suitable interval of time according to a particularembodiment based on various considerations, including the procedurebeing performed. Example intervals of time considered suitable include,but are not limited to, allowing one or more seconds to pass, one ormore minutes to pass, one or more hours to pass, one or more days topass, and any other interval of time considered suitable for aparticular application.

An optional step comprises adjusting the position of the elongate memberdistal end within the bodily passage. This can be accomplished byapplying a force on the actuator such that it moves between the actuatorfirst position and actuator second position and/or applying a force onthe deflectable catheter such that is advanced into or withdrawn fromthe bodily passage.

Step 1516 can be accomplished by applying a distally directed force onthe actuator such that it moves from the actuator first position to theactuator second position. The application of a distally directed forceon the actuator axially advances the wire member in the distal directionsuch that the elongate member moves from a curved configuration in whichelongate member defines one or more curves along its length to astraight, or substantially straight, configuration. Alternatively, step1516 can comprise advancing the actuator from the actuator secondposition, or a position between the actuator second position and theactuator first position, to a position between the actuator firstposition and the actuator second position.

Step 1518 can be accomplished by placing a proximally and/or distallydirected force on any suitable portion of a deflectable catheter suchthat it is withdrawn from the airway.

An optional step comprises confirming placement of the elongate memberand/or that the elongate member defines one or more curves along itslength. This optional step can be accomplished using any suitablestructure or method of visualization, and skilled artisans will be ableto select a suitable structure or method to visualize an elongate memberaccording to a particular embodiment based on various considerations,such as the desired bodily passage within which a deflectable catheteris intended to be deployed. Example structures and methods ofvisualization include, but are not limited, using direct visualization,fluoroscopy, a scope, transcutaneously, taking an x-ray, and any othermethod considered suitable for a particular application.

Another optional step comprises performing treatment. This optional stepcan be completed using any suitable device, system, or component. Forexample, this optional step can be completed by performing a sleep studyon a patient. Alternatively, or in combination with performing a sleepstudy, this optional step can be completed by introducing a fluid intothe irrigation tube to flush the airway. Alternatively, or incombination with performing a sleep study, this optional step can becompleted by applying suction to the irrigation tube to withdrawmaterial within the airway. Another optional step comprises cleaning theimaging device. This optional step can be completed by introducing afluid into the irrigation tube until the imaging device is clean.

Step 1520 can be accomplished by removing the first attachment memberfrom the first component until the proximal housing is free ofattachment to the first component.

Step 1522 can be accomplished by removing the second attachment memberfrom the second component until the handle of the deflectable catheteris free of attachment to the second component.

While various steps, alternative steps, and optional steps have beendescribed above with respect to visualizing an airway using adeflectable catheter system, these steps, alternative steps, andoptional steps can be included in, accomplished concurrently with,and/or accomplished in the alternative to, the method, steps,alternative steps, and/or optional steps described above with respect tomethod 500.

Those with ordinary skill in the art will appreciate that variousmodifications and alternatives for the described and illustratedembodiments can be developed in light of the overall teachings of thedisclosure. Accordingly, the particular arrangements disclosed areintended to be illustrative only and not limiting as to the scope of theinvention, which is to be given the full breadth of the appended claimsand any and all equivalents thereof.

What is claimed is:
 1. A deflectable catheter having a lengthwise axisand comprising: a handle having an actuator moveable between an actuatorfirst position and an actuator second position; an elongate membermoveable between a substantially straight configuration when theactuator is in the actuator first position and a curved configurationwhen the actuator is in the actuator second position, the elongatemember comprising: a first shaft attached to the handle and defining afirst shaft first lumen and a first shaft second lumen; a first flexiblemember attached to the first shaft, the first flexible member having afirst flexible member proximal end, a first flexible member distal end,and defining a first flexible member passageway in communication witheach of the first shaft first lumen and first shaft second lumen; asecond shaft attached to the first flexible member and defining a secondshaft first lumen and a second shaft second lumen, each of the secondshaft first lumen and second shaft second lumen in communication withthe first flexible member passageway, the second shaft first lumendisposed on a second shaft lengthwise axis that is parallel to saidlengthwise axis of said deflectable catheter when the elongate member isin the substantially straight configuration; a tubular member attachedto the second shaft and defining a tubular member lumen in communicationwith each of the second shaft first lumen and second shaft second lumen;a third shaft attached to the tubular member and defining a third shaftfirst lumen and a third shaft second lumen, each of the third shaftfirst lumen and third shaft second lumen in communication with thetubular member lumen, the third shaft second lumen disposed on a thirdshaft lengthwise axis that is parallel to said lengthwise axis of saiddeflectable catheter when the elongate member is in the substantiallystraight configuration; a second flexible member attached to the thirdshaft, the second flexible member having a second flexible memberproximal end, a second flexible member distal end, and defining a secondflexible member passageway in communication with each of the third shaftfirst lumen and third shaft second lumen; and a cap attached to thesecond flexible member; a wire member having a wire member first endattached to the actuator and a wire member second end attached to theelongate member, the wire member extending from the wire member firstend through the first shaft first lumen, through the first flexiblemember passageway, through the second shaft first lumen, through thetubular member lumen, through the third shaft second lumen, and throughthe second flexible member passageway; wherein the second shaftlengthwise axis and the third shaft lengthwise axis are opposablypositioned relative to said lengthwise axis of said deflectable catheterwhen the elongate member is in the substantially straight configuration.2. The deflectable catheter of claim 1, wherein the first flexiblemember defines a helical configuration that extends from the firstflexible member proximal end to the first flexible member distal end. 3.The deflectable catheter of claim 1, wherein the second flexible memberdefines a helical configuration that extends from the second flexiblemember proximal end to the second flexible member distal end.
 4. Thedeflectable catheter of claim 1, wherein at least one of the firstflexible member and the second flexible member comprises a compressionspring.
 5. The deflectable catheter of claim 1, wherein at least one ofthe first flexible member and the second flexible member comprises ahelically cut portion of the material that forms the elongate member. 6.The deflectable catheter of claim 1, wherein the first flexible memberis relatively more flexible than the first shaft.
 7. The deflectablecatheter of claim 1, wherein the second shaft lengthwise axis isdisposed on a first plane that contains said lengthwise axis of saiddeflectable catheter; wherein the third shaft lengthwise axis isdisposed on a second plane that contains said lengthwise axis of saiddeflectable catheter; and wherein the first plane and the second planeare coplanar.
 8. The deflectable catheter of claim 1, wherein the secondshaft lengthwise axis is disposed on a first plane that contains saidlengthwise axis of said deflectable catheter; wherein the third shaftlengthwise axis is disposed on a second plane that contains saidlengthwise axis of said deflectable catheter; and wherein the firstplane is disposed at an angle to the second plane.
 9. The deflectablecatheter of claim 1, further comprising a fourth shaft attached to thesecond flexible member between the second flexible member and the cap,the fourth shaft defining a fourth shaft first lumen and a fourth shaftsecond lumen, each of the fourth shaft first lumen and the fourth shaftsecond lumen in communication with the second flexible memberpassageway; wherein the wire member extends through the fourth shaftsecond lumen.
 10. A deflectable catheter having a lengthwise axis andcomprising: a handle having an actuator moveable between an actuatorfirst position and an actuator second position; an elongate membermoveable between a substantially straight configuration when theactuator is in the actuator first position and a curved configurationwhen the actuator is in the actuator second position, the elongatemember comprising: a first shaft attached to the handle and defining afirst shaft first lumen and a first shaft second lumen; a first flexiblemember attached to the first shaft, the first flexible member having afirst flexible member proximal end, a first flexible member distal end,and defining a first flexible member passageway in communication witheach of the first shaft first lumen and first shaft second lumen, thefirst flexible member defining a helical configuration that extends fromthe first flexible member proximal end to the first flexible memberdistal end; a second shaft attached to the first flexible member anddefining a second shaft first lumen and a second shaft second lumen,each of the second shaft first lumen and second shaft second lumen incommunication with the first flexible member passageway, the secondshaft first lumen disposed on a second shaft lengthwise axis that isparallel to said lengthwise axis of said deflectable catheter when theelongate member is in the substantially straight configuration; atubular member attached to the second shaft and defining a tubularmember lumen in communication with each of the second shaft first lumenand second shaft second lumen; a third shaft attached to the tubularmember and defining a third shaft first lumen and a third shaft secondlumen, each of the third shaft first lumen and third shaft second lumenin communication with the tubular member lumen, the third shaft secondlumen disposed on a third shaft lengthwise axis that is parallel to saidlengthwise axis of said deflectable catheter when the elongate member isin the substantially straight configuration; a second flexible memberattached to the third shaft, the second flexible member having a secondflexible member proximal end, a second flexible member distal end, anddefining a second flexible member passageway in communication with eachof the third shaft first lumen and third shaft second lumen, the secondflexible member defining a helical configuration that extends from thesecond flexible member proximal end to the second flexible member distalend; and a cap attached to the second flexible member; a wire memberhaving a wire member first end attached to the actuator and a wiremember second end attached to the elongate member, the wire memberextending from the wire member first end through the first shaft firstlumen, through the first flexible member passageway, through the secondshaft first lumen, through the tubular member lumen, through the thirdshaft second lumen, and through the second flexible member passageway;wherein the second shaft lengthwise axis and the third shaft lengthwiseaxis are opposably positioned relative to said lengthwise axis of saiddeflectable catheter when the elongate member is in the substantiallystraight configuration.
 11. The deflectable catheter of claim 10,wherein at least one of the first flexible member and the secondflexible member comprises a compression spring.
 12. The deflectablecatheter of claim 10, wherein at least one of the first flexible memberand the second flexible member comprises a helically cut portion of thematerial that forms the elongate member.
 13. The deflectable catheter ofclaim 10, wherein the first flexible member is relatively more flexiblethan the first shaft.
 14. The deflectable catheter of claim 10, whereinthe second shaft lengthwise axis is disposed on a first plane thatcontains said lengthwise axis of said deflectable catheter; wherein thethird shaft lengthwise axis is disposed on a second plane that containssaid lengthwise axis of said deflectable catheter; and wherein the firstplane and the second plane are coplanar.
 15. The deflectable catheter ofclaim 10, wherein the second shaft lengthwise axis is disposed on afirst plane that contains said lengthwise axis of said deflectablecatheter; wherein the third shaft lengthwise axis is disposed on asecond plane that contains said lengthwise axis of said deflectablecatheter; and wherein the first plane is disposed at an angle to thesecond plane.
 16. The deflectable catheter of claim 10, furthercomprising a fourth shaft attached to the second flexible member betweenthe second flexible member and the cap, the fourth shaft defining afourth shaft first lumen and a fourth shaft second lumen, each of thefourth shaft first lumen and the fourth shaft second lumen incommunication with the second flexible member passageway; wherein thewire member extends through the fourth shaft second lumen.
 17. Adeflectable catheter having a lengthwise axis and comprising: a handlehaving an actuator moveable between an actuator first position and anactuator second position; an elongate member moveable between asubstantially straight configuration when the actuator is in theactuator first position and a curved configuration when the actuator isin the actuator second position, the elongate member comprising: a firstshaft attached to the handle and defining a first shaft first lumen anda first shaft second lumen; a first flexible member comprising acompression spring attached to the first shaft, the first flexiblemember having a first flexible member proximal end, a first flexiblemember distal end, and defining a first flexible member passageway incommunication with each of the first shaft first lumen and first shaftsecond lumen, the first flexible member defining a helical configurationthat extends from the first flexible member proximal end to the firstflexible member distal end; a second shaft attached to the firstflexible member and defining a second shaft first lumen and a secondshaft second lumen, each of the second shaft first lumen and secondshaft second lumen in communication with the first flexible memberpassageway, the second shaft first lumen disposed on a second shaftlengthwise axis that is parallel to said lengthwise axis of saiddeflectable catheter when the elongate member is in the substantiallystraight configuration; a tubular member attached to the second shaftand defining a tubular member lumen in communication with each of thesecond shaft first lumen and second shaft second lumen; a third shaftattached to the tubular member and defining a third shaft first lumenand a third shaft second lumen, each of the third shaft first lumen andthird shaft second lumen in communication with the tubular member lumen,the third shaft second lumen disposed on a third shaft lengthwise axisthat is parallel to said lengthwise axis of said deflectable catheterwhen the elongate member is in the substantially straight configuration;a second flexible member comprising a compression spring attached to thethird shaft, the second flexible member having a second flexible memberproximal end, a second flexible member distal end, and defining a secondflexible member passageway in communication with each of the third shaftfirst lumen and third shaft second lumen, the second flexible memberdefining a helical configuration that extends from the second flexiblemember proximal end to the second flexible member distal end; and a capattached to the second flexible member; a wire member having a wiremember first end attached to the actuator and a wire member second endattached to the elongate member, the wire member extending from the wiremember first end through the first shaft first lumen, through the firstflexible member passageway, through the second shaft first lumen,through the tubular member lumen, through the third shaft second lumen,and through the second flexible member passageway; wherein the secondshaft lengthwise axis and the third shaft lengthwise axis are opposablypositioned relative to said lengthwise axis of said deflectable catheterwhen the elongate member is in the substantially straight configuration;wherein the second shaft lengthwise axis is disposed on a first planethat contains said lengthwise axis of said deflectable catheter; whereinthe third shaft lengthwise axis is disposed on a second plane thatcontains said lengthwise axis of said deflectable catheter; and whereinthe first plane and the second plane are coplanar.
 18. The deflectablecatheter of claim 17, wherein the first flexible member is relativelymore flexible than the first shaft.
 19. The deflectable catheter ofclaim 17, further comprising a fourth shaft attached to the secondflexible member between the second flexible member and the cap, thefourth shaft defining a fourth shaft first lumen and a fourth shaftsecond lumen, each of the fourth shaft first lumen and the fourth shaftsecond lumen in communication with the second flexible memberpassageway; wherein the wire member extends through the fourth shaftsecond lumen.
 20. The deflectable catheter of claim 19, wherein thefourth shaft second lumen is coaxial with the third shaft second lumen.